case study in group discussion

A Step-by-Step Guide To Case Discussion

By ashi jain.

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Are you comfortable in Decision Making in a given situation How aptly you analyze the situation with a logical approach How much time do you take in arriving at a decision How good are you in taking the rightful course of action

Solved Example:

Hari, the only working member of the family has been working an organization for 25 years. His job required long standing hours. One day, while working, he lost his leg in an accident. The company paid for his medical reimbursement.

Since he was a hardworking employee; the company offered him another compensatory job. He refused by saying, ‘Once a Lion, always a Lion’. As an HR, what solution would you suggest?

Identification of the Problem:

Obvious: accident, refusal of job, only earning member, his attitude, and inability to do his current job Hidden: the reputation of the company at stake, the course of action might influence other employees

Action Plan:

As an HR, you are first expected to check the company records and find out how a similar case has been dealt with in the past. Second, you need to take cognizance of the track record of the employee highlighted by the keyword ‘hardworking’.

Given the situation at hand, he is deemed unfit for his current role. However, the problem arises because of his attitude towards the compensatory job. Hence, in such a case, counselling is required.

Here, three levels of Counselling is required: 1.   Ist level is with Hari 2.   IInd level of counselling is required with the Union Leader (if any) to keep the collective interest and the reputation of the company in mind 3.   IIIrd level of counselling is required with his family members as they constitute of the afflicted party

If the counselling does not work, one should also identify a contingency plan or Plan B. In this case, the Contingency Plan would be – hire someone from his family for a compensatory role.

Note that the following options are out of scope and should be avoided: 1.   Increase Hari’s salary so that he gives in and agrees to do the compensatory job 2.   Status Quo – do not bother as long as the Company is making a profit 3.   Replace Hari with someone else

1. Pinpoint the key issues to be solved and identify their cause and effects

2. Start broad and try to work through a range of issues methodically

3. Connect the facts and evidence and focus on the big picture

4. Discuss any trade-offs or implications of your proposed solution

5. Relate your conclusion back to the problem statement and make sure you have answered all the questions

1. Do not be anxious if you are not able to understand the situation well or unable to justify the problem. Read again, a little slowly, it will help you understand better.

2. Do not jump to conclusions; try to move systematically and gradually.

3. Do not panic if you are unable to analyze the situation. Listen carefully to others as the discussion starts, it will help you gauge the problem at hand.

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Facilitating a Case Discussion

Have a plan, but be ready to adjust it

Enter each case discussion with a plan that includes the major topics you hope to cover (with rough time estimates) and the questions you hope to ask for each topic. Be as flexible as you can about how and when the topics are covered, and allow the participants to drive the discussion.

Ask Good Questions

Strive to make your questions interesting (a good measure is your own interest in the answer), clear, and as concise as possible. Emphasize questions that require judgment and analysis rather than purely factual responses. You want as many students as possible to be engaged and interested in joining the discussion. Vary your question types and style to avoid being predictable and keep students engaged.

When calling on students, consider three strategies: an open call , where you call on volunteers; a warm call , where you provide advance notice to a student before or during class before calling on them; and a cold call , where you call on them without any prior warning and when they did not volunteer. If you choose to allow students to speak without raising their hands, be careful to monitor the impact on the distribution of who speaks when—those comfortable speaking out may not be representative of all of your students.

Listen Attentively and Monitor Airtime

If you want students to be engaged and listen to each other, you must also be sure to listen well yourself. Use what you hear to drive your follow-up questions and the next student you call on. As the facilitator, you need to balance the opportunities to speak in class as well as the amount of “airtime” each student gets. The airtime need not be equal in each class session, but track this over time to keep it in balance.

Allow Space to Adjust

Your teaching plan will include several key themes to cover. As you consider transitions, ask yourself a few key questions: Have you covered the key issues in the discussion? What remains to be covered? Is it imperative to cover that material today rather than in a subsequent class?

Incorporate Group Work

Small groups in and outside class can elevate the discussions and increase student engagement. Having teams prepare cases together gives students an opportunity to test ideas and lower the preparation burden. Within class, small groups can accelerate analysis, fill in gaps in preparation, and set up debates. Be sure to give groups clear instructions, and make use of any deliverables they create.

Embrace the Open-Ended

Most students will crave clear answers at the end of each case discussion. Be wary of sharing prefabricated slides with conclusions, and rely more on students to provide the lessons. Call on students to share their thoughts (these can be warm calls at the start of class), have small groups generate their takeaways, or leave students with a question to ponder rather than answers to write down. Vary how you wrap up each class to stay unpredictable.

The Art of Cold Calling

The Perfect Opening Question

Questions for Class Discussion

What to Do When Students Bring Case Solutions to Class

More Key Topics

Getting Started with Case Teaching

Key considerations as you begin your case teaching journey

Teaching Cases in Hybrid Settings

How to balance the needs of both your in-person and remote students

Selecting Cases to Use in Your Classes

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Structuring the Case Discussion

Well-designed cases are intentionally complex. Therefore, presenting an entire case to students all at once has the potential to overwhelm student groups and lead them to overlook key details or analytic steps. Accordingly, Barbara Cockrill asks students to review key case concepts the night before, and then presents the case in digestible “chunks” during a CBCL session. Structuring the case discussion around key in-depth questions, Cockrill creates a thoughtful interplay between small group work and whole group discussion that makes for more systematic forays into the case at hand.

Barbara Cockrill , Harold Amos Academy Associate Professor of Medicine

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Harvard Medical School

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First-year requisite

• Classroom Considerations
• Relevant Research
• Related Resources
• CBCL provides students the opportunity to apply course material in new ways. For this reason, you might consider not sharing the case with students beforehand and having them experience it in class with fresh eyes.
• Chunk cases so students can focus on case specifics and gradually build-up to greater complexity and understanding. 
• Introduce variety into case-based discussions. Integrate a mix of independent work, small group discussion, and whole group share outs to keep students engaged and provide multiple junctures for students to get feedback on their understanding.
• Instructor scaffolding is critical for effective case-based learning ( Ramaekers et al., 2011 )
• This resource from the Harvard Business School provides suggestions for questioning, listening, and responding during a case discussion .
• This comprehensive resource on “The ABCs of Case Teaching” provides helpful tips for planning and “running” your case .

Related Moves

Experiencing the Case as a Student Team

Regulating the Flow of Energy in the Classroom

Designing Focused Discussions for Relevance and Transfer of Knowledge

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Case Study At-A-Glance

A case study is a way to let students interact with material in an open-ended manner. the goal is not to find solutions, but to explore possibilities and options of a real-life scenario..

Want examples of a Case-Study?  Check out the ABLConnect Activity Database Want to read research supporting the Case-Study method? Click here

Why should you facilitate a Case Study?

Want to facilitate a case-study in your class .

How-To Run a Case-Study

• Before class pick the case study topic/scenario. You can either generate a fictional situation or can use a real-world example.
• Clearly let students know how they should prepare. Will the information be given to them in class or do they need to do readings/research before coming to class?
• Have a list of questions prepared to help guide discussion (see below)
• Sessions work best when the group size is between 5-20 people so that everyone has an opportunity to participate. You may choose to have one large whole-class discussion or break into sub-groups and have smaller discussions. If you break into groups, make sure to leave extra time at the end to bring the whole class back together to discuss the key points from each group and to highlight any differences.
• What is the problem?
• What is the cause of the problem?
• Who are the key players in the situation? What is their position?
• What are the relevant data?
• What are possible solutions – both short-term and long-term?
• What are alternate solutions? – Play (or have the students play) Devil’s Advocate and consider alternate view points
• What are potential outcomes of each solution?
• What other information do you want to see?
• What can we learn from the scenario?
• Be flexible. While you may have a set of questions prepared, don’t be afraid to go where the discussion naturally takes you. However, be conscious of time and re-focus the group if key points are being missed
• Role-playing can be an effective strategy to showcase alternate viewpoints and resolve any conflicts
• Involve as many students as possible. Teamwork and communication are key aspects of this exercise. If needed, call on students who haven’t spoken yet or instigate another rule to encourage participation.
• Write out key facts on the board for reference. It is also helpful to write out possible solutions and list the pros/cons discussed.
• Having the information written out makes it easier for students to reference during the discussion and helps maintain everyone on the same page.
• Keep an eye on the clock and make sure students are moving through the scenario at a reasonable pace. If needed, prompt students with guided questions to help them move faster.  
• Either give or have the students give a concluding statement that highlights the goals and key points from the discussion. Make sure to compare and contrast alternate viewpoints that came up during the discussion and emphasize the take-home messages that can be applied to future situations.
• Inform students (either individually or the group) how they did during the case study. What worked? What didn’t work? Did everyone participate equally?
• Taking time to reflect on the process is just as important to emphasize and help students learn the importance of teamwork and communication.

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Harvard Business School: Teaching By the Case-Study Method

Written by Catherine Weiner

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• Section 4. Techniques for Leading Group Discussions

Chapter 16 Sections

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• Section 2. Developing Facilitation Skills
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A local coalition forms a task force to address the rising HIV rate among teens in the community.  A group of parents meets to wrestle with their feeling that their school district is shortchanging its students.  A college class in human services approaches the topic of dealing with reluctant participants.  Members of an environmental group attend a workshop on the effects of global warming.  A politician convenes a “town hall meeting” of constituents to brainstorm ideas for the economic development of the region.  A community health educator facilitates a smoking cessation support group.

All of these might be examples of group discussions, although they have different purposes, take place in different locations, and probably run in different ways.  Group discussions are common in a democratic society, and, as a community builder, it’s more than likely that you have been and will continue to be involved in many of them.  You also may be in a position to lead one, and that’s what this section is about.  In this last section of a chapter on group facilitation, we’ll examine what it takes to lead a discussion group well, and how you can go about doing it.

What is an effective group discussion?

The literal definition of a group discussion is obvious: a critical conversation about a particular topic, or perhaps a range of topics, conducted in a group of a size that allows participation by all members.  A group of two or three generally doesn’t need a leader to have a good discussion, but once the number reaches five or six, a leader or facilitator can often be helpful.  When the group numbers eight or more, a leader or facilitator, whether formal or informal, is almost always helpful in ensuring an effective discussion.

A group discussion is a type of meeting, but it differs from the formal meetings in a number of ways: It may not have a specific goal – many group discussions are just that: a group kicking around ideas on a particular topic.  That may lead to a goal ultimately...but it may not. It’s less formal, and may have no time constraints, or structured order, or agenda. Its leadership is usually less directive than that of a meeting. It emphasizes process (the consideration of ideas) over product (specific tasks to be accomplished within the confines of the meeting itself. Leading a discussion group is not the same as running a meeting.  It’s much closer to acting as a facilitator, but not exactly the same as that either.

An effective group discussion generally has a number of elements:

• All members of the group have a chance to speak, expressing their own ideas and feelings freely, and to pursue and finish out their thoughts
• All members of the group can hear others’ ideas and feelings stated openly
• Group members can safely test out ideas that are not yet fully formed
• Group members can receive and respond to respectful but honest and constructive feedback.  Feedback could be positive, negative, or merely clarifying or correcting factual questions or errors, but is in all cases delivered respectfully.
• A variety of points of view are put forward and discussed
• The discussion is not dominated by any one person
• Arguments, while they may be spirited, are based on the content of ideas and opinions, not on personalities
• Even in disagreement, there’s an understanding that the group is working together to resolve a dispute, solve a problem, create a plan, make a decision, find principles all can agree on, or come to a conclusion from which it can move on to further discussion

Many group discussions have no specific purpose except the exchange of ideas and opinions.  Ultimately, an effective group discussion is one in which many different ideas and viewpoints are heard and considered.  This allows the group to accomplish its purpose if it has one, or to establish a basis either for ongoing discussion or for further contact and collaboration among its members.

There are many possible purposes for a group discussion, such as:

• Create a new situation – form a coalition, start an initiative, etc.
• Explore cooperative or collaborative arrangements among groups or organizations
• Discuss and/or analyze an issue, with no specific goal in mind but understanding
• Create a strategic plan – for an initiative, an advocacy campaign, an intervention, etc.
• Discuss policy and policy change
• Air concerns and differences among individuals or groups
• Hold public hearings on proposed laws or regulations, development, etc.
• Decide on an action
• Provide mutual support
• Solve a problem
• Resolve a conflict
• Plan your work or an event

Possible leadership styles of a group discussion also vary.  A group leader or facilitator might be directive or non-directive; that is, she might try to control what goes on to a large extent; or she might assume that the group should be in control, and that her job is to facilitate the process.  In most group discussions, leaders who are relatively non-directive make for a more broad-ranging outlay of ideas, and a more satisfying experience for participants.

Directive leaders can be necessary in some situations. If a goal must be reached in a short time period, a directive leader might help to keep the group focused. If the situation is particularly difficult, a directive leader might be needed to keep control of the discussion and make

Why would you lead a group discussion?

There are two ways to look at this question: “What’s the point of group discussion?” and “Why would you, as opposed to someone else, lead a group discussion?”  Let’s examine both.

What’s the point of group discussion?

As explained in the opening paragraphs of this section, group discussions are common in a democratic society.  There are a number of reasons for this, some practical and some philosophical.

A group discussion:

• G ives everyone involved a voice .  Whether the discussion is meant to form a basis for action, or just to play with ideas, it gives all members of the group a chance to speak their opinions, to agree or disagree with others, and to have their thoughts heard.  In many community-building situations, the members of the group might be chosen specifically because they represent a cross-section of the community, or a diversity of points of view.
• Allows for a variety of ideas to be expressed and discussed .  A group is much more likely to come to a good conclusion if a mix of ideas is on the table, and if all members have the opportunity to think about and respond to them.
• Is generally a democratic, egalitarian process .  It reflects the ideals of most grassroots and community groups, and encourages a diversity of views.
• Leads to group ownership of whatever conclusions, plans, or action the group decides upon .  Because everyone has a chance to contribute to the discussion and to be heard, the final result feels like it was arrived at by and belongs to everyone.
• Encourages those who might normally be reluctant to speak their minds .  Often, quiet people have important things to contribute, but aren’t assertive enough to make themselves heard.  A good group discussion will bring them out and support them.
• Can often open communication channels among people who might not communicate in any other way .  People from very different backgrounds, from opposite ends of the political spectrum, from different cultures, who may, under most circumstances, either never make contact or never trust one another enough to try to communicate, might, in a group discussion, find more common ground than they expected.
• Is sometimes simply the obvious, or even the only, way to proceed.  Several of the examples given at the beginning of the section – the group of parents concerned about their school system, for instance, or the college class – fall into this category, as do public hearings and similar gatherings.

Why would you specifically lead a group discussion?

You might choose to lead a group discussion, or you might find yourself drafted for the task.  Some of the most common reasons that you might be in that situation:

• It’s part of your job .  As a mental health counselor, a youth worker, a coalition coordinator, a teacher, the president of a board of directors, etc. you might be expected to lead group discussions regularly.
• You’ve been asked to .  Because of your reputation for objectivity or integrity, because of your position in the community, or because of your skill at leading group discussions, you might be the obvious choice to lead a particular discussion.
• A discussion is necessary, and you’re the logical choice to lead it .  If you’re the chair of a task force to address substance use in the community, for instance, it’s likely that you’ll be expected to conduct that task force’s meetings, and to lead discussion of the issue.
• It was your idea in the first place .  The group discussion, or its purpose, was your idea, and the organization of the process falls to you.

You might find yourself in one of these situations if you fall into one of the categories of people who are often tapped to lead group discussions.  These categories include (but aren’t limited to):

• Directors of organizations
• Public officials
• Coalition coordinators
• Professionals with group-leading skills – counselors, social workers, therapists, etc.
• Health professionals and health educators
• Respected community members.  These folks may be respected for their leadership – president of the Rotary Club, spokesperson for an environmental movement – for their positions in the community – bank president, clergyman – or simply for their personal qualities – integrity, fairness, ability to communicate with all sectors of the community.
• Community activists.  This category could include anyone from “professional” community organizers to average citizens who care about an issue or have an idea they want to pursue.

When might you lead a group discussion?

The need or desire for a group discussion might of course arise anytime, but there are some times when it’s particularly necessary.

• At the start of something new . Whether you’re designing an intervention, starting an initiative, creating a new program, building a coalition, or embarking on an advocacy or other campaign, inclusive discussion is likely to be crucial in generating the best possible plan, and creating community support for and ownership of it.
• When an issue can no longer be ignored . When youth violence reaches a critical point, when the community’s drinking water is declared unsafe, when the HIV infection rate climbs – these are times when groups need to convene to discuss the issue and develop action plans to swing the pendulum in the other direction.
• When groups need to be brought together . One way to deal with racial or ethnic hostility, for instance, is to convene groups made up of representatives of all the factions involved.  The resulting discussions – and the opportunity for people from different backgrounds to make personal connections with one another – can go far to address everyone’s concerns, and to reduce tensions.
• When an existing group is considering its next step or seeking to address an issue of importance to it . The staff of a community service organization, for instance, may want to plan its work for the next few months, or to work out how to deal with people with particular quirks or problems.

How do you lead a group discussion?

In some cases, the opportunity to lead a group discussion can arise on the spur of the moment; in others, it’s a more formal arrangement, planned and expected.  In the latter case, you may have the chance to choose a space and otherwise structure the situation.  In less formal circumstances, you’ll have to make the best of existing conditions.

We’ll begin by looking at what you might consider if you have time to prepare.  Then we’ll examine what it takes to make an effective discussion leader or facilitator, regardless of external circumstances.

Set the stage

If you have time to prepare beforehand, there are a number of things you may be able to do to make the participants more comfortable, and thus to make discussion easier.

Choose the space

If you have the luxury of choosing your space, you might look for someplace that’s comfortable and informal.  Usually, that means comfortable furniture that can be moved around (so that, for instance, the group can form a circle, allowing everyone to see and hear everyone else easily).  It may also mean a space away from the ordinary.

One organization often held discussions on the terrace of an old mill that had been turned into a bookstore and café.  The sound of water from the mill stream rushing by put everyone at ease, and encouraged creative thought.

Provide food and drink

The ultimate comfort, and one that breaks down barriers among people, is that of eating and drinking.

Bring materials to help the discussion along

Most discussions are aided by the use of newsprint and markers to record ideas, for example.

Become familiar with the purpose and content of the discussion

If you have the opportunity, learn as much as possible about the topic under discussion.  This is not meant to make you the expert, but rather to allow you to ask good questions that will help the group generate ideas.

Make sure everyone gets any necessary information, readings, or other material beforehand

If participants are asked to read something, consider questions, complete a task, or otherwise prepare for the discussion, make sure that the assignment is attended to and used.  Don’t ask people to do something, and then ignore it.

Lead the discussion

Think about leadership style

The first thing you need to think about is leadership style, which we mentioned briefly earlier in the section.  Are you a directive or non-directive leader?  The chances are that, like most of us, you fall somewhere in between the extremes of the leader who sets the agenda and dominates the group completely, and the leader who essentially leads not at all. The point is made that many good group or meeting leaders are, in fact, facilitators, whose main concern is supporting and maintaining the process of the group’s work.  This is particularly true when it comes to group discussion, where the process is, in fact, the purpose of the group’s coming together.

A good facilitator helps the group set rules for itself, makes sure that everyone participates and that no one dominates, encourages the development and expression of all ideas, including “odd” ones, and safeguards an open process, where there are no foregone conclusions and everyone’s ideas are respected.  Facilitators are non-directive, and try to keep themselves out of the discussion, except to ask questions or make statements that advance it.  For most group discussions, the facilitator role is probably a good ideal to strive for.

It’s important to think about what you’re most comfortable with philosophically, and how that fits what you’re comfortable with personally.  If you’re committed to a non-directive style, but you tend to want to control everything in a situation, you may have to learn some new behaviors in order to act on your beliefs.

Put people at ease

Especially if most people in the group don’t know one another, it’s your job as leader to establish a comfortable atmosphere and set the tone for the discussion.

Help the group establish ground rules

The ground rules of a group discussion are the guidelines that help to keep the discussion on track, and prevent it from deteriorating into namecalling or simply argument.  Some you might suggest, if the group has trouble coming up with the first one or two:

• Everyone should treat everyone else with respect : no name-calling, no emotional outbursts, no accusations.
• No arguments directed at people – only at ideas and opinions .  Disagreement should be respectful – no ridicule.
• Don’t interrupt .  Listen to the whole of others’ thoughts – actually listen, rather than just running over your own response in your head.
• Respect the group’s time .  Try to keep your comments reasonably short and to the point, so that others have a chance to respond.
• Consider all comments seriously, and try to evaluate them fairly .  Others’ ideas and comments may change your mind, or vice versa: it’s important to be open to that.
• Don’t be defensive if someone disagrees with you .  Evaluate both positions, and only continue to argue for yours if you continue to believe it’s right.
• Everyone is responsible for following and upholding the ground rules .

Ground rules may also be a place to discuss recording the session.  Who will take notes, record important points, questions for further discussion, areas of agreement or disagreement?  If the recorder is a group member, the group and/or leader should come up with a strategy that allows her to participate fully in the discussion.

Generate an agenda or goals for the session

You might present an agenda for approval, and change it as the group requires, or you and the group can create one together.  There may actually be no need for one, in that the goal may simply be to discuss an issue or idea.  If that’s the case, it should be agreed upon at the outset.

How active you are might depend on your leadership style, but you definitely have some responsibilities here.  They include setting, or helping the group to set the discussion topic; fostering the open process; involving all participants; asking questions or offering ideas to advance the discussion; summarizing or clarifying important points, arguments, and ideas; and wrapping up the session.  Let’s look at these, as well as some do’s and don’t’s for discussion group leaders.

• Setting the topic . If the group is meeting to discuss a specific issue or to plan something, the discussion topic is already set.  If the topic is unclear, then someone needs to help the group define it.  The leader – through asking the right questions, defining the problem, and encouraging ideas from the group – can play that role.
• Fostering the open process . Nurturing the open process means paying attention to the process, content, and interpersonal dynamics of the discussion all at the same time – not a simple matter. As leader, your task is not to tell the group what to do, or to force particular conclusions, but rather to make sure that the group chooses an appropriate topic that meets its needs, that there are no “right” answers to start with (no foregone conclusions), that no one person or small group dominates the discussion, that everyone follows the ground rules, that discussion is civil and organized, and that all ideas are subjected to careful critical analysis.  You might comment on the process of the discussion or on interpersonal issues when it seems helpful (“We all seem to be picking on John here – what’s going on?”), or make reference to the open process itself (“We seem to be assuming that we’re supposed to believe X – is that true?”). Most of your actions as leader should be in the service of modeling or furthering the open process.

Part of your job here is to protect “minority rights,” i.e., unpopular or unusual ideas.  That doesn’t mean you have to agree with them, but that you have to make sure that they can be expressed, and that discussion of them is respectful, even in disagreement. (The exceptions are opinions or ideas that are discriminatory or downright false.)  Odd ideas often turn out to be correct, and shouldn’t be stifled.

• Involving all participants . This is part of fostering the open process, but is important enough to deserve its own mention. To involve those who are less assertive or shy, or who simply can’t speak up quickly enough, you might ask directly for their opinion, encourage them with body language (smile when they say anything, lean and look toward them often), and be aware of when they want to speak and can’t break in.  It’s important both for process and for the exchange of ideas that everyone have plenty of opportunity to communicate their thoughts.
• Asking questions or offering ideas to advance the discussion . The leader should be aware of the progress of the discussion, and should be able to ask questions or provide information or arguments that stimulate thinking or take the discussion to the next step when necessary. If participants are having trouble grappling with the topic, getting sidetracked by trivial issues, or simply running out of steam, it’s the leader’s job to carry the discussion forward.

This is especially true when the group is stuck, either because two opposing ideas or factions are at an impasse, or because no one is able or willing to say anything.  In these circumstances, the leader’s ability to identify points of agreement, or to ask the question that will get discussion moving again is crucial to the group’s effectiveness.

• Summarizing or clarifying important points, arguments, or ideas . This task entails making sure that everyone understands a point that was just made, or the two sides of an argument.  It can include restating a conclusion the group has reached, or clarifying a particular idea or point made by an individual (“What I think I heard you say was…”).  The point is to make sure that everyone understands what the individual or group actually meant.
• Wrapping up the session .  As the session ends, the leader should help the group review the discussion and make plans for next steps (more discussion sessions, action, involving other people or groups, etc.). He should also go over any assignments or tasks that were agreed to, make sure that every member knows what her responsibilities are, and review the deadlines for those responsibilities.  Other wrap-up steps include getting feedback on the session – including suggestions for making it better – pointing out the group’s accomplishments, and thanking it for its work.

Even after you’ve wrapped up the discussion, you’re not necessarily through. If you’ve been the recorder, you might want to put the notes from the session in order, type them up, and send them to participants. The notes might also include a summary of conclusions that were reached, as well as any assignments or follow-up activities that were agreed on.

If the session was one-time, or was the last of a series, your job may now be done. If it was the beginning, however, or part of an ongoing discussion, you may have a lot to do before the next session, including contacting people to make sure they’ve done what they promised, and preparing the newsprint notes to be posted at the next session so everyone can remember the discussion.

Leading an effective group discussion takes preparation (if you have the opportunity for it), an understanding of and commitment to an open process, and a willingness to let go of your ego and biases. If you can do these things, the chances are you can become a discussion leader that can help groups achieve the results they want.

Do’s and don’ts for discussion leaders

• Model the behavior and attitudes you want group members to employ . That includes respecting all group members equally; advancing the open process; demonstrating what it means to be a learner (admitting when you’re wrong, or don’t know a fact or an answer, and suggesting ways to find out); asking questions based on others’ statements; focusing on positions rather than on the speaker; listening carefully; restating others’ points; supporting your arguments with fact or logic; acceding when someone else has a good point; accepting criticism; thinking critically; giving up the floor when appropriate; being inclusive and culturally sensitive, etc.
• Use encouraging body language and tone of voice, as well as words .  Lean forward when people are talking, for example, keep your body position open and approachable, smile when appropriate, and attend carefully to everyone, not just to those who are most articulate.
• Give positive feedback for joining the discussion .  Smile, repeat group members’ points, and otherwise show that you value participation.
• Be aware of people’s reactions and feelings, and try to respond appropriately . If a group member is hurt by others’ comments, seems puzzled or confused, is becoming angry or defensive, it’s up to you as discussion leader to use the ground rules or your own sensitivity to deal with the situation. If someone’s hurt, for instance, it may be important to point that out and discuss how to make arguments without getting personal.  If group members are confused, revisiting the comments or points that caused the confusion, or restating them more clearly, may be helpful.  Being aware of the reactions of individuals and of the group as a whole can make it possible to expose and use conflict, or to head off unnecessary emotional situations and misunderstandings.
• Ask open-ended questions .  In advancing the discussion, use questions that can’t be answered with a simple yes or no.  Instead, questions should require some thought from group members, and should ask for answers that include reasons or analysis.  The difference between “Do you think the President’s decision was right?” and “Why do you think the President’s decision was or wasn’t right?” is huge.  Where the first question can be answered with a yes or no, the second requires an analysis supporting the speaker’s opinion, as well as discussion of the context and reasons for the decision.
• Control your own biases .  While you should point out factual errors or ideas that are inaccurate and disrespectful of others, an open process demands that you not impose your views on the group, and that you keep others from doing the same.  Group members should be asked to make rational decisions about the positions or views they want to agree with, and ultimately the ideas that the group agrees on should be those that make the most sense to them – whether they coincide with yours or not.  Pointing out bias – including your own – and discussing it helps both you and group members try to be objective.

A constant question that leaders – and members – of any group have is what to do about racist, sexist, or homophobic remarks, especially in a homogeneous group where most or all of the members except the leader may agree with them.  There is no clear-cut answer, although if they pass unchallenged, it may appear you condone the attitude expressed. How you challenge prejudice is the real question.  The ideal here is that other members of the group do the challenging, and it may be worth waiting long enough before you jump in to see if that’s going to happen.  If it doesn’t, you can essentially say, “That’s wrong, and I won’t allow that kind of talk here,” which may well put an end to the remarks, but isn’t likely to change anyone’s mind.  You can express your strong disagreement or discomfort with such remarks and leave it at that, or follow up with “Let’s talk about it after the group,” which could generate some real discussion about prejudice and stereotypes, and actually change some thinking over time. Your ground rules – the issue of respecting everyone – should address this issue, and it probably won’t come up…but there are no guarantees.  It won’t hurt to think beforehand about how you want to handle it.

• Encourage disagreement, and help the group use it creatively .  Disagreement is not to be smoothed over, but rather to be analyzed and used.  When there are conflicting opinions – especially when both can be backed up by reasonable arguments – the real discussion starts.  If everyone agrees on every point, there’s really no discussion at all.  Disagreement makes people think.  It may not be resolved in one session, or at all, but it’s the key to discussion that means something.

All too often, conflict – whether conflicting opinions, conflicting world views, or conflicting personalities – is so frightening to people that they do their best to ignore it or gloss it over.  That reaction not only leaves the conflict unresolved – and therefore growing, so that it will be much stronger when it surfaces later– but fails to examine the issues that it raises.  If those are brought out in the open and discussed reasonably, the two sides often find that they have as much agreement as disagreement, and can resolve their differences by putting their ideas together.  Even where that’s not the case, facing the conflict reasonably, and looking at the roots of the ideas on each side, can help to focus on the issue at hand and provide solutions far better than if one side or the other simply operated alone.

• Keep your mouth shut as much as possible .  By and large, discussion groups are for the group members.  You may be a member of the group and have been asked by the others to act as leader, in which case you certainly have a right to be part of the discussion (although not to dominate).  If you’re an outside facilitator, or leader by position, it’s best to confine your contributions to observations on process, statements of fact, questions to help propel the discussion, and clarification and summarization.  The simple fact that you’re identified as leader or facilitator gives your comments more force than those of other group members.  If you’re in a position of authority or seen as an expert, that force becomes even greater.  The more active you are in the discussion, the more the group will take your positions and ideas as “right,” and the less it will come to its own conclusions.
• Don’t let one or a small group of individuals dominate the discussion .  People who are particularly articulate or assertive, who have strong feelings that they urgently want to express, or who simply feel the need – and have the ability – to dominate can take up far more than their fair share of a discussion.  This often means that quieter people have little or no chance to speak, and that those who disagree with the dominant individual(s) are shouted down and cease trying to make points.  It’s up to the leader to cut off individuals who take far more than their share of time, or who try to limit discussion.  This can be done in a relatively non-threatening way (“This is an interesting point, and it’s certainly worth the time we’ve spent on it, but there are other points of view that need to be heard as well.  I think Alice has been waiting to speak…”), but it’s crucial to the open process and to the comfort and effectiveness of the group.
• Don’t let one point of view override others , unless it’s based on facts and logic, and is actually convincing group members to change their minds.  If a point of view dominates because of its merits, its appeal to participants’ intellectual and ethical sensibilities, that’s fine.  It’s in fact what you hope will happen in a good group discussion.  If a point of view dominates because of the aggressiveness of its supporters, or because it’s presented as something it’s wrong to oppose (“People who disagree with the President are unpatriotic and hate their country”), that’s intellectual bullying or blackmail, and is the opposite of an open discussion.  As leader, you should point it out when that’s happening, and make sure other points of view are aired and examined.

Sometimes individuals or factions that are trying to dominate can disrupt the process of the group. Both Sections 1 and 2 of this chapter contain some guidelines for dealing with this type of situation.

• Don’t assume that anyone holds particular opinions or positions because of his culture, background, race, personal style, etc .  People are individuals, and can’t be judged by their exteriors.  You can find out what someone thinks by asking, or by listening when he speaks.
• Don’t assume that someone from a particular culture, race, or background speaks for everyone else from that situation .  She may or may not represent the general opinion of people from situations similar to hers…or there may not be a general opinion among them.  In a group discussion, no one should be asked or assumed to represent anything more than herself.

The exception here is when someone has been chosen by her community or group to represent its point of view in a multi-sector discussion.  Even in that situation, the individual may find herself swayed by others’ arguments, or may have ideas of her own.  She may have agreed to sponsor particular ideas that are important to her group, but she may still have her own opinions as well, especially in other areas.

• Don’t be the font of all wisdom .  Even if you know more about the discussion topic than most others in the group (if you’re the teacher of a class, for instance), presenting yourself as the intellectual authority denies group members the chance to discuss the topic freely and without pressure.  Furthermore, some of them may have ideas you haven’t considered, or experiences that give them insights into the topic that you’re never likely to have.  Model learning behavior, not teaching behavior.

If you’re asked your opinion directly, you should answer honestly.  You have some choices about how you do that, however.  One is to state your opinion, but make very clear that it’s an opinion, not a fact, and that other people believe differently.  Another is to ask to hold your opinion until the end of the discussion, so as not to influence anyone’s thinking while it’s going on.  Yet another is to give your opinion after all other members of the group have stated theirs, and then discuss the similarities and differences among all the opinions and people’s reasons for holding them. If you’re asked a direct question, you might want to answer it if it’s a question of fact and you know the answer, and if it’s relevant to the discussion.  If the question is less clear-cut, you might want to throw it back to the group, and use it as a spur to discussion.

Group discussions are common in our society, and have a variety of purposes, from planning an intervention or initiative to mutual support to problem-solving to addressing an issue of local concern.  An effective discussion group depends on a leader or facilitator who can guide it through an open process – the group chooses what it’s discussing, if not already determined, discusses it with no expectation of particular conclusions, encourages civil disagreement and argument, and makes sure that every member is included and no one dominates.  It helps greatly if the leader comes to the task with a democratic or, especially, a collaborative style, and with an understanding of how a group functions.

A good group discussion leader has to pay attention to the process and content of the discussion as well as to the people who make up the group.  She has to prepare the space and the setting to the extent possible; help the group establish ground rules that will keep it moving civilly and comfortably; provide whatever materials are necessary; familiarize herself with the topic; and make sure that any pre-discussion readings or assignments get to participants in plenty of time.  Then she has to guide the discussion, being careful to promote an open process; involve everyone and let no one dominate; attend to the personal issues and needs of individual group members when they affect the group; summarize or clarify when appropriate; ask questions to keep the discussion moving, and put aside her own agenda, ego, and biases.

It’s not an easy task, but it can be extremely rewarding.  An effective group discussion can lay the groundwork for action and real community change.

Online resources

Everyday-Democracy . Study Circles Resource Center. Information and publications related to study circles, participatory discussion groups meant to address community issues.

Facilitating Political Discussions from the Institute for Democracy and Higher Education at Tufts University is designed to assist experienced facilitators in training others to facilitate politically charged conversations. The materials are broken down into "modules" and facilitation trainers can use some or all of them to suit their needs.

Project on Civic Reflection provides information about leading study circles on civic reflection.

“ Suggestions for Leading Small-Group Discussions ,” prepared by Lee Haugen, Center for Teaching Excellence, Iowa State University, 1998. Tips on university teaching, but much of the information is useful in other circumstances as well.

“ Tips for Leading Discussions ,” by Felisa Tibbits, Human Rights Education Associates.

Print resources

Forsyth, D . Group Dynamics . (2006). (4th edition).  Belmont, CA: Thomson Wadsworth. 

Johnson, D., & Frank P. (2002). Joining Together: Group theory and group skills . (8th edition).  Boston: Allyn & Bacon.

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What Is a Case Study?

Weighing the pros and cons of this method of research

Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Cara Lustik is a fact-checker and copywriter.

Verywell / Colleen Tighe

• Pros and Cons

What Types of Case Studies Are Out There?

Where do you find data for a case study, how do i write a psychology case study.

A case study is an in-depth study of one person, group, or event. In a case study, nearly every aspect of the subject's life and history is analyzed to seek patterns and causes of behavior. Case studies can be used in many different fields, including psychology, medicine, education, anthropology, political science, and social work.

The point of a case study is to learn as much as possible about an individual or group so that the information can be generalized to many others. Unfortunately, case studies tend to be highly subjective, and it is sometimes difficult to generalize results to a larger population.

While case studies focus on a single individual or group, they follow a format similar to other types of psychology writing. If you are writing a case study, we got you—here are some rules of APA format to reference.  

At a Glance

A case study, or an in-depth study of a person, group, or event, can be a useful research tool when used wisely. In many cases, case studies are best used in situations where it would be difficult or impossible for you to conduct an experiment. They are helpful for looking at unique situations and allow researchers to gather a lot of˜ information about a specific individual or group of people. However, it's important to be cautious of any bias we draw from them as they are highly subjective.

What Are the Benefits and Limitations of Case Studies?

A case study can have its strengths and weaknesses. Researchers must consider these pros and cons before deciding if this type of study is appropriate for their needs.

One of the greatest advantages of a case study is that it allows researchers to investigate things that are often difficult or impossible to replicate in a lab. Some other benefits of a case study:

• Allows researchers to capture information on the 'how,' 'what,' and 'why,' of something that's implemented
• Gives researchers the chance to collect information on why one strategy might be chosen over another
• Permits researchers to develop hypotheses that can be explored in experimental research

On the other hand, a case study can have some drawbacks:

• It cannot necessarily be generalized to the larger population
• Cannot demonstrate cause and effect
• It may not be scientifically rigorous
• It can lead to bias

Researchers may choose to perform a case study if they want to explore a unique or recently discovered phenomenon. Through their insights, researchers develop additional ideas and study questions that might be explored in future studies.

It's important to remember that the insights from case studies cannot be used to determine cause-and-effect relationships between variables. However, case studies may be used to develop hypotheses that can then be addressed in experimental research.

Case Study Examples

There have been a number of notable case studies in the history of psychology. Much of  Freud's work and theories were developed through individual case studies. Some great examples of case studies in psychology include:

• Anna O : Anna O. was a pseudonym of a woman named Bertha Pappenheim, a patient of a physician named Josef Breuer. While she was never a patient of Freud's, Freud and Breuer discussed her case extensively. The woman was experiencing symptoms of a condition that was then known as hysteria and found that talking about her problems helped relieve her symptoms. Her case played an important part in the development of talk therapy as an approach to mental health treatment.
• Phineas Gage : Phineas Gage was a railroad employee who experienced a terrible accident in which an explosion sent a metal rod through his skull, damaging important portions of his brain. Gage recovered from his accident but was left with serious changes in both personality and behavior.
• Genie : Genie was a young girl subjected to horrific abuse and isolation. The case study of Genie allowed researchers to study whether language learning was possible, even after missing critical periods for language development. Her case also served as an example of how scientific research may interfere with treatment and lead to further abuse of vulnerable individuals.

Such cases demonstrate how case research can be used to study things that researchers could not replicate in experimental settings. In Genie's case, her horrific abuse denied her the opportunity to learn a language at critical points in her development.

This is clearly not something researchers could ethically replicate, but conducting a case study on Genie allowed researchers to study phenomena that are otherwise impossible to reproduce.

There are a few different types of case studies that psychologists and other researchers might use:

• Collective case studies : These involve studying a group of individuals. Researchers might study a group of people in a certain setting or look at an entire community. For example, psychologists might explore how access to resources in a community has affected the collective mental well-being of those who live there.
• Descriptive case studies : These involve starting with a descriptive theory. The subjects are then observed, and the information gathered is compared to the pre-existing theory.
• Explanatory case studies : These   are often used to do causal investigations. In other words, researchers are interested in looking at factors that may have caused certain things to occur.
• Exploratory case studies : These are sometimes used as a prelude to further, more in-depth research. This allows researchers to gather more information before developing their research questions and hypotheses .
• Instrumental case studies : These occur when the individual or group allows researchers to understand more than what is initially obvious to observers.
• Intrinsic case studies : This type of case study is when the researcher has a personal interest in the case. Jean Piaget's observations of his own children are good examples of how an intrinsic case study can contribute to the development of a psychological theory.

The three main case study types often used are intrinsic, instrumental, and collective. Intrinsic case studies are useful for learning about unique cases. Instrumental case studies help look at an individual to learn more about a broader issue. A collective case study can be useful for looking at several cases simultaneously.

The type of case study that psychology researchers use depends on the unique characteristics of the situation and the case itself.

There are a number of different sources and methods that researchers can use to gather information about an individual or group. Six major sources that have been identified by researchers are:

• Archival records : Census records, survey records, and name lists are examples of archival records.
• Direct observation : This strategy involves observing the subject, often in a natural setting . While an individual observer is sometimes used, it is more common to utilize a group of observers.
• Documents : Letters, newspaper articles, administrative records, etc., are the types of documents often used as sources.
• Interviews : Interviews are one of the most important methods for gathering information in case studies. An interview can involve structured survey questions or more open-ended questions.
• Participant observation : When the researcher serves as a participant in events and observes the actions and outcomes, it is called participant observation.
• Physical artifacts : Tools, objects, instruments, and other artifacts are often observed during a direct observation of the subject.

If you have been directed to write a case study for a psychology course, be sure to check with your instructor for any specific guidelines you need to follow. If you are writing your case study for a professional publication, check with the publisher for their specific guidelines for submitting a case study.

Here is a general outline of what should be included in a case study.

Section 1: A Case History

This section will have the following structure and content:

Background information : The first section of your paper will present your client's background. Include factors such as age, gender, work, health status, family mental health history, family and social relationships, drug and alcohol history, life difficulties, goals, and coping skills and weaknesses.

Description of the presenting problem : In the next section of your case study, you will describe the problem or symptoms that the client presented with.

Describe any physical, emotional, or sensory symptoms reported by the client. Thoughts, feelings, and perceptions related to the symptoms should also be noted. Any screening or diagnostic assessments that are used should also be described in detail and all scores reported.

Your diagnosis : Provide your diagnosis and give the appropriate Diagnostic and Statistical Manual code. Explain how you reached your diagnosis, how the client's symptoms fit the diagnostic criteria for the disorder(s), or any possible difficulties in reaching a diagnosis.

Section 2: Treatment Plan

This portion of the paper will address the chosen treatment for the condition. This might also include the theoretical basis for the chosen treatment or any other evidence that might exist to support why this approach was chosen.

• Cognitive behavioral approach : Explain how a cognitive behavioral therapist would approach treatment. Offer background information on cognitive behavioral therapy and describe the treatment sessions, client response, and outcome of this type of treatment. Make note of any difficulties or successes encountered by your client during treatment.
• Humanistic approach : Describe a humanistic approach that could be used to treat your client, such as client-centered therapy . Provide information on the type of treatment you chose, the client's reaction to the treatment, and the end result of this approach. Explain why the treatment was successful or unsuccessful.
• Psychoanalytic approach : Describe how a psychoanalytic therapist would view the client's problem. Provide some background on the psychoanalytic approach and cite relevant references. Explain how psychoanalytic therapy would be used to treat the client, how the client would respond to therapy, and the effectiveness of this treatment approach.
• Pharmacological approach : If treatment primarily involves the use of medications, explain which medications were used and why. Provide background on the effectiveness of these medications and how monotherapy may compare with an approach that combines medications with therapy or other treatments.

This section of a case study should also include information about the treatment goals, process, and outcomes.

When you are writing a case study, you should also include a section where you discuss the case study itself, including the strengths and limitiations of the study. You should note how the findings of your case study might support previous research. 

In your discussion section, you should also describe some of the implications of your case study. What ideas or findings might require further exploration? How might researchers go about exploring some of these questions in additional studies?

Need More Tips?

Here are a few additional pointers to keep in mind when formatting your case study:

• Never refer to the subject of your case study as "the client." Instead, use their name or a pseudonym.
• Read examples of case studies to gain an idea about the style and format.
• Remember to use APA format when citing references .

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach .  BMC Med Res Methodol . 2011;11:100.

Crowe S, Cresswell K, Robertson A, Huby G, Avery A, Sheikh A. The case study approach . BMC Med Res Methodol . 2011 Jun 27;11:100. doi:10.1186/1471-2288-11-100

Gagnon, Yves-Chantal.  The Case Study as Research Method: A Practical Handbook . Canada, Chicago Review Press Incorporated DBA Independent Pub Group, 2010.

Yin, Robert K. Case Study Research and Applications: Design and Methods . United States, SAGE Publications, 2017.

By Kendra Cherry, MSEd Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Growth Tactics

Types of Group Discussion: Strategies for Effective Discussions

• 1 Understanding Group Discussion
• 2 Types of Group Discussion
• 3 Choosing a Suitable Topic
• 4 Strategies for Effective Group Discussions
• 5 Common Challenges in Group Discussions and How to Overcome Them
• 6 Technology and Group Discussions
• 7 Conclusion

Group discussion is a valuable tool for learning, collaboration, and fostering critical thinking skills. Whether you are a student preparing for an exam, an educator looking for ways to engage your students, or a leader trying to solve a problem, understanding the different types of group discussions, topics, and strategies is essential. In this blog post, we will explore the various types of group discussions, how to choose a suitable topic, and strategies for facilitating meaningful and productive discussions.

Understanding Group Discussion

Group discussions are a form of interactive communication that involves a small group of individuals sharing their thoughts, ideas, and opinions on a specific topic. These discussions can take place in various settings, such as classrooms, organizations, or professional settings, and can serve different purposes, such as problem-solving, decision-making, or brainstorming.

Types of Group Discussion

Group discussions offer a dynamic environment for sharing thoughts, ideas, and opinions. They can be beneficial for learning, collaboration, and developing critical thinking skills . Let’s explore three types of group discussions: case-based discussions, topic-based discussions, and structured group discussions.

1. Case-Based Discussions

In case-based discussions, participants analyze and discuss specific cases or scenarios. They evaluate possible solutions or approaches, which helps develop problem-solving and analytical skills. By actively engaging with real or hypothetical case studies, participants enhance their ability to think critically about complex situations.

2. Topic-Based Discussions

Topic-based discussions center around a specific subject or theme. Participants express their opinions, present arguments, and explore different viewpoints. These discussions improve communication skills and foster critical thinking as participants analyze and evaluate various perspectives on a given topic.

3. Structured Group Discussions

Structured group discussions follow predefined formats or rules. A moderator guides the discussion by posing questions and facilitating conversation. This format ensures active participation and constructive exchanges, providing a framework for focused and productive discussions.

By understanding the different types of group discussions, participants can choose the most suitable format for their goals and create an engaging and interactive environment for meaningful conversations.

Choosing a Suitable Topic

Selecting an appropriate topic is crucial for a successful group discussion. Consider the following factors when choosing a topic:

1. Relevance to the Participants

The topic should be relevant to the participants’ interests, experiences, or areas of study. This helps create a sense of engagement and encourages active participation.

2. Controversial and Thought-Provoking

Controversial topics or those that require critical thinking and analysis can spark lively and meaningful discussions. Avoid vague or overly simplistic topics that do not stimulate thoughtful discussion.

3. Current Affairs and Real-World Issues

Discussing current affairs and real-world issues helps participants develop an understanding of the socio-economic and political landscape. These topics encourage participants to think critically and evaluate different perspectives.

Strategies for Effective Group Discussions

To make group discussions productive and engaging, consider implementing the following strategies:

1. Establish Clear Ground Rules

Start by establishing clear guidelines and expectations for the discussion. These ground rules should emphasize the importance of active listening, respectful communication, and equal participation. By setting a foundation of mutual respect and inclusivity, you create a safe and open environment for all participants to contribute their ideas.

2. Encourage the Expression of Diverse Perspectives

Promote a culture that values and encourages diverse perspectives. Encourage participants to share their unique viewpoints, experiences, and ideas. By actively seeking and embracing different perspectives, you enrich the conversation and foster a deeper understanding of the topic at hand. Remember that diversity of thought leads to more innovative and creative solutions.

3. Foster Lateral Thinking and Problem-Solving

Encourage participants to think critically and approach problems from various angles. Foster an environment that values and promotes lateral thinking, which involves exploring unconventional or alternative solutions. Encourage participants to challenge assumptions and consider different perspectives to generate innovative ideas and solutions.

4. Provide Structured Discussion Prompts

Prepare a list of discussion prompts or questions in advance to guide the conversation. These prompts should cover various aspects of the topic and encourage participants to think critically and express their thoughts. Structured discussion prompts provide a framework and keep the conversation focused and productive. This helps ensure that all important aspects of the topic are explored.

5. Facilitate Active Participation

Actively engage all participants to facilitate their active participation in the discussion. Encourage quieter participants to contribute by directly asking for their input or by creating a supportive environment that encourages them to share their thoughts. By ensuring that everyone feels heard and valued, you create a space for meaningful and collaborative discussions.

By implementing these strategies, you can make your group discussions more effective, inclusive, and thought-provoking. These approaches promote critical thinking, enhance problem-solving skills, and allow for the exploration of multiple perspectives. Remember that an open and respectful environment is key to fostering successful group discussions.

Common Challenges in Group Discussions and How to Overcome Them

Group discussions can be an effective way to generate ideas, facilitate collaboration, and arrive at well-informed decisions. However, there are common challenges that can arise during group discussions. Here are some of these challenges and strategies to overcome them:

1. Dominant Personalities

Some participants may have dominant personalities that can overpower the conversation, making others feel unheard or overshadowed. To prevent dominance, set equal speaking opportunities for everyone. Encourage active listening to make sure everyone’s voice is heard. If someone is dominating the conversation, try direct questions to other participants and redirecting the conversation towards the quieter members.

2. Groupthink

Groupthink occurs when the desire for group harmony leads to conformity and a lack of critical thinking. To avoid it, make sure to encourage diverse opinions, ideas, and perspectives. Assign a designated devil’s advocate whose role is to challenge proposed ideas. Anonymous ideation sessions and setting the tone of every idea is welcome helps in the same.

3. Lack of Focus

Conversations may easily veer off-topic or lack a clear focus, making it difficult to achieve the intended goals. Keep the conversation focused by setting and reviewing an agenda periodically. Encourage participants to take constructive breaks that revitalize their focus. Use summarizing techniques throughout the discussion to align the focus.

4. Unequal Participation

In some situations, certain individuals may dominate conversations while others stay silent. Encourage participation by assigning specific roles, and asking directly for input from quieter participants. Brainstorming techniques can be used like round-robin, think-pair-share, or small groups to ensure equal participation.

5. Conflict Resolution

Conflicts or disagreements may arise during group discussions, leading to stress and uncertainty. To handle conflicts constructively, encourage active listening, acknowledging different perspectives and viewpoints, facilitating open dialogue, and seeking win-win solutions. By creating an open and inclusive space to resolve conflicts, the group’s dynamics and outcomes will enhance positively.

By proactively addressing these common challenges, groups can have meaningful conversations that lead to actionable insights and productive solutions.

Technology and Group Discussions

Technology has revolutionized the way we communicate and collaborate in group settings. With the rise of virtual meetings, video conferencing, and online collaboration tools, it’s now easier than ever to conduct group discussions from anywhere in the world. However, with these benefits come new challenges as well. Here are some ways technology can impact group discussions and how to overcome them.

Pros of Using Technology in Group Discussions

Increased Flexibility and Accessibility : With online tools, group members can join meetings from anywhere, at any time. This allows for greater flexibility and accessibility, making it easier for people to participate in group discussions even if they are not physically present.

Improved Collaboration : Virtual tools allow group members to collaborate in real-time, regardless of their physical location. This makes it easier for members to share ideas and information, and work together to achieve a common goal.

Reduced Costs : Virtual meetings can significantly reduce costs associated with travel and facility rental. This makes it easier for groups with limited resources to conduct discussions without sacrificing the benefits of in-person meetings.

Cons of Using Technology in Group Discussions

Technical Difficulties : Technical difficulties can arise during virtual meetings, which can delay progress and cause frustration. This can be overcome by having all participants test the technology before the meeting and ensuring all participants have a stable internet connection.

Lack of Non-Verbal Cues : During virtual meetings, non-verbal cues such as body language and facial expressions can be difficult to read. To overcome this, group members must be clear and concise with their verbal communication.

Distractions : Since virtual meetings can be conducted from anywhere, it’s easy for participants to become distracted by their surroundings. To overcome this, establish ground rules for participants such as turning off notifications or finding a quiet space to participate in the discussion.

In conclusion, technology has revolutionized the way we conduct group discussions and collaboration. By being aware of the pros and cons of using virtual meetings and online collaboration tools, groups can take advantage of the benefits while mitigating the challenges.

Group discussions are an effective way to promote critical thinking, collaboration, and communication skills . By understanding the different types of group discussions, selecting suitable topics, and implementing effective strategies, educators and students can foster engaging and productive discussions. Remember to establish ground rules, encourage diverse perspectives, and provide structured prompts to make the most out of your group discussions.

Key Takeaways

• Group discussions can take various forms, including case-based and topic-based discussions.
• Choosing a relevant and thought-provoking topic is crucial for effective discussions.
• Strategies such as establishing ground rules and encouraging diverse perspectives enhance the quality of group discussions .
• Active participation and structured discussion prompts facilitate meaningful conversations.

This Is What You Need to Know to Pass Your Group Case Interview

• Last Updated January, 2024

If you’re on this page, chances are you’ve been told you’re scheduled for a group interview. 

After practicing for weeks to get good at cracking a normal case interview, hearing you have a group interview might make you feel like you’ve scaled a huge mountain only to find that there’s an even higher peak beyond it that you need to climb.

Group case interviews present some different challenges than individual cases, but if you know what those challenges are, you can overcome them. 

We’ll tell you how. 

In this article, we’ll cover what a group case interview is, why consulting firms use them, the key to passing your group interview, and tell you the 6 tips on group interviews you need to know.

If this is your first time to MyConsultingOffer.org, you may want to start with this page  on  Case Interview Prep . But if you’re ready to learn everything you need to know to pass a group case, you’re in the right place.

Let’s get started!

What is a Group Case Interview?

The group needs to come to a collective point of view on what the client’s problem is, how to structure their analysis, and what the final recommendation should be. 

The group should also agree on how the analysis of the case will be conducted at a high level, but the actual number-crunching will need to be divided between group members in order to complete the work in the allotted time.

The group’s analysis and recommendation will be presented to one or more interviewers.

Why Do Consulting Firms Use Group Case Interviews?

It can feel difficult to trust your team members when you know that you’re all competing for the same job, but that’s what the group case is about — it tests teamwork skills in a high-stakes environment.

Management consultants are hired to solve big, thorny business problems, ones that require the work of multiple people to solve. 

While there is a hierarchy on consulting teams with a partner leading the work, consulting partners simultaneously manage multiple clients or multiple studies at one large client. 

They won’t work with your team every day and in their absence, the team still needs to be able to work together effectively.

Even if a partner is leading a team’s problem-solving discussion, each consultant has a responsibility to make sure the team’s best thinking is being put forward to help the client. 

Ideas are both expected from each member of the team and valued. 

Even the newest analyst has a contribution to make.

T he analyst may have been the person to analyze the data and therefore be closest to the information that will drive the solution to the problem. 

The flat power-structure of the team makes it critical that each consultant works well with others on teams.

In assessing each member of a group case team, interviewers will ask themselves:

Does each of the recruits listen as well as lead?

Are they open to other peoples’ ideas?

Can they perform independent analysis and interpret what impact their work has on the overall problem the team is trying to solve?

Can they persuade team members of their points of view?

The Key to Passing the Group Case: Make Sure Your Group Is Organized

A group case must be solved by going through the same 4 steps as individual cases :   the opening, structuring the problem, the analysis, and the recommendation. 

Your team should break down the time you have to solve the case into time allotted to each of these steps to ensure you don’t spend too long in one area and not reach a recommendation. 

Make sure the team agrees on a single statement of the client’s problem.

Take the time for everyone to read the materials, take notes, and suggest what they think is the key question(s) that need to be solved in this case.

Write it on a whiteboard or somewhere else to ensure there’s agreement. You can’t solve the problem together if you don’t agree on what the problem is. 

Usually, someone in the group will take the lead on organizing the group.

If no one does, this is your opportunity to demonstrate your leadership and teamwork skills, but if there are people fighting over the leadership position (unlikely since everyone is on their “best behavior”), then contribute and don’t worry that you aren’t “leading” the discussion just yet.

Create a clear,  MECE  structure to analyze the problem.

This is even more important to solving a group case than an individual one because you need to make sure that when the group breaks up so each member can perform part of the analysis, all the issues are covered and there’s not duplicated effort between team members.

After your group structures the problem, split up the analysis that needs to be done between members of the group.

If no one suggests breaking up the analysis, then volunteer the idea. Be sure to explain how each person’s piece fits into the team effort.

Each person should do their analysis independently to ensure there is sufficient time to complete all the required tasks, though the team should regroup briefly if someone has a problem they need help with or comes up with an insight that could influence the work other group members are doing. 

While you do your own analysis, you’ll need to demonstrate you understand the bigger picture by involving your teammates, sharing how your findings impacts their work, and articulating how all the insights lead to an answer to the client’s problem.

After everyone has completed their analysis, the group should come back together so everyone can report their results and the group can collectively come to a recommendation to present to interviewers.

In addition to the normal 4 parts of the case, group cases usually require you to present your recommendation to the interviewer(s).

Be sure to build time into your schedule for creating slides, deciding who presents what, and practicing your delivery. 

Many groups fail because they begin their presentation without deciding who has which role.

In consulting, this is like going into a client meeting without knowing who is presenting which slide to the client and makes your team look unprofessional.

Presentation

Start with your recommendation and then provide the key pieces of analysis and/or reasoning that support it.

Again, the work will need to be divided between team members to ensure you get slides written in the allotted time.

For more information on writing good slide presentations, see  Written Case Interview  page.

6 Tips to Pass Your Group Case Interview

Tip 1: organize your team.

A disorganized team will not be able to complete their analysis and develop a strong recommendation in the time allotted.

See the previous section for the steps the group needs to complete to solve the case.

If someone else does take charge, don’t fight for control.

Show leadership by making points that help to move the team’s problem solving forward, not fighting so that it goes backwards. 

Tip 2: Move the Problem-Solving Forward

With multiple team members trying to contribute and express their point of view, it’s possible to have a lot of discussion without getting closer to a solution to the client’s business problem. You can overcome this by:

• Summing up what the team has agreed on so far,
• Providing insight into how the team’s discussion impacts the problem you’re tasked with solving, and/or
• Steering the team to discuss the next steps.

If it feels like the team is rehashing the same topics, use these options to move the problem solving forward.

Tip 3: Make Fact-Based Decisions

It’s okay to disagree with team members but always disagree like a consultant. Challenge teammates’ ideas with data, not opinions.

If there is analysis that needs to be done to determine which point of view is correct, table the discussion until the analysis has been completed.

Tip 4: Don't Steamroll Teammates

As mentioned earlier, consulting teams value the ideas and input of every team member.

Because of this, cutting off, interrupting or talking over other team members is more likely to get you turned down for a consulting job than hired.

The quality of your contribution to group discussions is more important than the quantity (or air time) you consume.

Demonstrate your collaboration and interpersonal skills.

Tip 5: Remain Confident When the Team Presents

Keep your poker face on even if your teammates don’t make every point the way you would have made it. 

Like steamrolling teammates in discussions, frowning or shaking your head as they present will make it look like you’re not a team player.

Tip 6: Remember, Everyone Can Get Offers

 In many jobs, there is only one position open.

At consulting firms, a class of new analysts and associates is hired each year.

There aren’t quotas regarding hiring only one person from a group interview team, so working cooperatively to solve the problem is a better strategy than undermining other members of your group to appear smarter than they are.

We’ve seen group interviews where no one gets a job offer and that can be because teammates undermine each other.

Don’t Over-Invest in Prepping for a Group Case Study Interview

Like the  written case interview , group cases come up infrequently. 

The 2 most common types of case interviews are individual interviews: the candidate-led interview or the interviewer-led interview.

In the candidate-led interview , the recruit is responsible for moving the problem solving forward. After they ensure they understand the problem and structure how they’d approach solving it, they pick one piece of the problem to start drilling down on first. Candidate-led cases are commonly used by Bain and BCG.

In the interviewer-led interview , the interviewer will suggest the first part of the case a recruit should probe after they have presented their opening and structured the problem. Interviewer-led interviews are commonly used by  McKinsey .

Because individual cases are much more common than group cases, don’t spend time preparing for a group case unless you’re sure you’ll have one. 

If you’re invited to take part in a group case interview, your preparation on individual cases will ensure you have a good approach cracking the case.

At this point, we hope you feel confident you can pass your group case interview. 

In this article, we’ve covered what a group case interview is, why consulting firms use them, the key to passing your group interview, and the 6 tips on group interviews you need to know.

Still have questions?

If you have more questions about group interviews, leave them in the comments below. One of My Consulting Offer’s case coaches will answer them.

People prepping for a group case interview have also found the following other pages helpful:

• Case Interview Math ,
• Written Case Interview , and 
• Bain One Way Interview . 

Help with Case Study Interview Preparation

Thanks for turning to My Consulting Offer for advice on case study interview prep. My Consulting Offer has helped almost 85% of the people we’ve worked with get a job in management consulting. We want you to be successful in your consulting interviews too.

If you want a step-by-step solution to land more offers from consulting firms, then  grab the free video training series below.  It’s been created by former Bain, BCG, and McKinsey Consultants, Managers and Recruiters.

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Discussion Tools: Case Studies

Instructional tools that promote active, participatory learning are widely recognized as the most effective way to engage trainees, convey knowledge, develop skills, and change attitudes.

What is Research Ethics

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Case Studies

Other Discussion Tools

Information about the history and authors of the Resources for Research Ethics Collection

Case studies are a tool for discussing scientific integrity. Although one of the most frequently used tools for encouraging discussion, cases are only one of many possible tools. Many of the principles discussed below for discussing case studies can be generalized to other approaches to encouraging discussion about research ethics. Cases are designed to confront readers with specific real-life problems that do not lend themselves to easy answers. Case discussion demands critical and analytical skills and, when implemented in small groups, also fosters collaboration (Pimple, 2002). By providing a focus for discussion, cases help trainees to define or refine their own standards, to appreciate alternative approaches to identifying and resolving ethical problems, and to develop skills for analyzing and dealing with hard problems on their own. The effective use of case studies is comprised of many factors, including:

• appropriate selection of case(s) (topic, relevance, length, complexity)
• method of case presentation (verbal, printed, before or during discussion)
• format for case discussion (Email or Internet-based, small group, large group)
• leadership of case discussion (choice of discussion leader, roles and responsibilities for discussion leader)
• outcomes for case discussion (answers to specific questions, answers to general questions, written or verbal summaries)

It should be noted that ethical decision-making is a process rather than a specific correct answer. In this sense, unethical behavior is defined by a failure to engage in the process of ethical decision-making. It is always unacceptable to have made no reasonable attempt to define a consistent and defensible basis for conduct.  

Leading Case Discussions

For the sake of time and clarity of purpose, it is essential that one individual have responsibility for leading the group discussion. As a minimum, this responsibility should include:

• Reading the case aloud.
• Defining, and re-defining as needed, the questions to be answered.
• Encouraging discussion that is "on topic".
• Discouraging discussion that is "off topic".
• Keeping the pace of discussion appropriate to the time available.
• Eliciting contributions from all members of the discussion group.
• Summarizing both majority and minority opinions at the end of the discussion.

How should cases be analyzed?

Many of the skills necessary to analyze case studies can become tools for responding to real world problems. Cases, like the real world, contain uncertainties and ambiguities. Readers are encouraged to identify key issues, make assumptions as needed, and articulate options for resolution. In addition to the specific questions accompanying each case, readers might consider the following questions:

• Who are the affected parties (individuals, institutions, a field, society) in this situation?
• What interest(s) (material, financial, ethical, other) does each party have in the situation? Which interests are in conflict?
• Were the actions taken by each of the affected parties acceptable (ethical, legal, moral, or common sense)? If not, are there circumstances under which those actions would have been acceptable? Who should impose what sanction(s)?
• What other courses of action are open to each of the affected parties? What is the likely outcome of each course of action?
• For each party involved, what course of action would you take, and why?
• What actions could have been taken to avoid the conflict?

If consensus is not possible, then written or oral summaries should reflect majority and minority opinions.  

Is there a right answer?

ACCEPTABLE SOLUTIONS: Most problems will have several acceptable solutions or answers, but it will not always be the case that a perfect solution can be found. At times, even the best solution will still have some unsatisfactory consequences. UNACCEPTABLE SOLUTIONS: While more than one acceptable solution may be possible, not all solutions are acceptable. For example, obvious violations of specific rules and regulations or of generally accepted standards of conduct would typically be unacceptable. However, it is also plausible that blind adherence to accepted rules or standards would sometimes be an unacceptable course of action.

• Bebeau MJ with Pimple KD, Muskavitch KMT, Borden SL, Smith DH (1995): Moral Reasoning in Scientific Research: Cases for Teaching and Assessment . Indiana University.
• Elliott D, Stern JE (1997): Research Ethics - A Reader. University Press of New England, Hanover, NH.
• OEC Resources: Cases
• Ellison, Karin and Karin Wellner. (2013) Research, Ethics, and Society Cases: Discussion Guide , Online Ethics Center.
• The Case Method , Center for Innovation in Teaching & Learning, University of Illinois at Urbana-Champaign
• Herreid CF: National Center for Case Study Teaching in Science, State University of New York at Buffalo. This comprehensive site offers methodology, a case study collection, case study teachers, workshops, and links to additional resources. https://web.archive.org/web/20071006070923/http://ublib.buffalo.edu/libraries/projects/cases/case.html  
• Korenman SG, Shipp AC (1994): Teaching the Responsible Conduct of Research through a Case Study Approach: A Handbook for Instructors. Association of American Medical Colleges, Washington, DC.
• Macrina FL (2005): Scientific Integrity: An Introductory Text with Cases. 3rd edition, American Society for Microbiology Press, Washington, DC.
• National Academy of Sciences (2009): On Being a Scientist: Responsible Conduct in Research . 3rd Edition. Publication from the Committee on Science, Engineering, and Public Policy, National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. National Academy Press, Washington DC.
• Penslar RL, ed. (1995): Research Ethics: Cases and Materials. Indiana University Press, Bloomington, IN.
• Pimple, KD (2002): Using Case Studies in Teaching Research Ethics
• Pimple KD (2002): Using Small Group Assignments in Teaching Research Ethics
• Schrag B, ed. (1996-2007): Graduate Research Ethics: Cases and Commentaries , Volumes 1-7, Association for Practical and Professional Ethics, Bloomington, Indiana.  

The Resources for Research Ethics Education site was originally developed and maintained by Dr. Michael Kalichman, Director of the Research Ethics Program at the University of California San Diego. The site was transferred to the Online Ethics Center in 2021 with the permission of the author.

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This material is based upon work supported by the National Science Foundation under Award No. 2055332. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

Organizing Your Social Sciences Research Assignments

• Annotated Bibliography
• Analyzing a Scholarly Journal Article
• Group Presentations
• Dealing with Nervousness
• Using Visual Aids
• Grading Someone Else's Paper
• Types of Structured Group Activities
• Group Project Survival Skills
• Leading a Class Discussion
• Multiple Book Review Essay
• Reviewing Collected Works
• Writing a Case Analysis Paper
• Writing a Case Study
• About Informed Consent
• Writing Field Notes
• Writing a Policy Memo
• Writing a Reflective Paper
• Writing a Research Proposal
• Generative AI and Writing
• Acknowledgments

A case study research paper examines a person, place, event, condition, phenomenon, or other type of subject of analysis in order to extrapolate  key themes and results that help predict future trends, illuminate previously hidden issues that can be applied to practice, and/or provide a means for understanding an important research problem with greater clarity. A case study research paper usually examines a single subject of analysis, but case study papers can also be designed as a comparative investigation that shows relationships between two or more subjects. The methods used to study a case can rest within a quantitative, qualitative, or mixed-method investigative paradigm.

Case Studies. Writing@CSU. Colorado State University; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010 ; “What is a Case Study?” In Swanborn, Peter G. Case Study Research: What, Why and How? London: SAGE, 2010.

How to Approach Writing a Case Study Research Paper

General information about how to choose a topic to investigate can be found under the " Choosing a Research Problem " tab in the Organizing Your Social Sciences Research Paper writing guide. Review this page because it may help you identify a subject of analysis that can be investigated using a case study design.

However, identifying a case to investigate involves more than choosing the research problem . A case study encompasses a problem contextualized around the application of in-depth analysis, interpretation, and discussion, often resulting in specific recommendations for action or for improving existing conditions. As Seawright and Gerring note, practical considerations such as time and access to information can influence case selection, but these issues should not be the sole factors used in describing the methodological justification for identifying a particular case to study. Given this, selecting a case includes considering the following:

• The case represents an unusual or atypical example of a research problem that requires more in-depth analysis? Cases often represent a topic that rests on the fringes of prior investigations because the case may provide new ways of understanding the research problem. For example, if the research problem is to identify strategies to improve policies that support girl's access to secondary education in predominantly Muslim nations, you could consider using Azerbaijan as a case study rather than selecting a more obvious nation in the Middle East. Doing so may reveal important new insights into recommending how governments in other predominantly Muslim nations can formulate policies that support improved access to education for girls.
• The case provides important insight or illuminate a previously hidden problem? In-depth analysis of a case can be based on the hypothesis that the case study will reveal trends or issues that have not been exposed in prior research or will reveal new and important implications for practice. For example, anecdotal evidence may suggest drug use among homeless veterans is related to their patterns of travel throughout the day. Assuming prior studies have not looked at individual travel choices as a way to study access to illicit drug use, a case study that observes a homeless veteran could reveal how issues of personal mobility choices facilitate regular access to illicit drugs. Note that it is important to conduct a thorough literature review to ensure that your assumption about the need to reveal new insights or previously hidden problems is valid and evidence-based.
• The case challenges and offers a counter-point to prevailing assumptions? Over time, research on any given topic can fall into a trap of developing assumptions based on outdated studies that are still applied to new or changing conditions or the idea that something should simply be accepted as "common sense," even though the issue has not been thoroughly tested in current practice. A case study analysis may offer an opportunity to gather evidence that challenges prevailing assumptions about a research problem and provide a new set of recommendations applied to practice that have not been tested previously. For example, perhaps there has been a long practice among scholars to apply a particular theory in explaining the relationship between two subjects of analysis. Your case could challenge this assumption by applying an innovative theoretical framework [perhaps borrowed from another discipline] to explore whether this approach offers new ways of understanding the research problem. Taking a contrarian stance is one of the most important ways that new knowledge and understanding develops from existing literature.
• The case provides an opportunity to pursue action leading to the resolution of a problem? Another way to think about choosing a case to study is to consider how the results from investigating a particular case may result in findings that reveal ways in which to resolve an existing or emerging problem. For example, studying the case of an unforeseen incident, such as a fatal accident at a railroad crossing, can reveal hidden issues that could be applied to preventative measures that contribute to reducing the chance of accidents in the future. In this example, a case study investigating the accident could lead to a better understanding of where to strategically locate additional signals at other railroad crossings so as to better warn drivers of an approaching train, particularly when visibility is hindered by heavy rain, fog, or at night.
• The case offers a new direction in future research? A case study can be used as a tool for an exploratory investigation that highlights the need for further research about the problem. A case can be used when there are few studies that help predict an outcome or that establish a clear understanding about how best to proceed in addressing a problem. For example, after conducting a thorough literature review [very important!], you discover that little research exists showing the ways in which women contribute to promoting water conservation in rural communities of east central Africa. A case study of how women contribute to saving water in a rural village of Uganda can lay the foundation for understanding the need for more thorough research that documents how women in their roles as cooks and family caregivers think about water as a valuable resource within their community. This example of a case study could also point to the need for scholars to build new theoretical frameworks around the topic [e.g., applying feminist theories of work and family to the issue of water conservation].

Eisenhardt, Kathleen M. “Building Theories from Case Study Research.” Academy of Management Review 14 (October 1989): 532-550; Emmel, Nick. Sampling and Choosing Cases in Qualitative Research: A Realist Approach . Thousand Oaks, CA: SAGE Publications, 2013; Gerring, John. “What Is a Case Study and What Is It Good for?” American Political Science Review 98 (May 2004): 341-354; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Seawright, Jason and John Gerring. "Case Selection Techniques in Case Study Research." Political Research Quarterly 61 (June 2008): 294-308.

Structure and Writing Style

The purpose of a paper in the social sciences designed around a case study is to thoroughly investigate a subject of analysis in order to reveal a new understanding about the research problem and, in so doing, contributing new knowledge to what is already known from previous studies. In applied social sciences disciplines [e.g., education, social work, public administration, etc.], case studies may also be used to reveal best practices, highlight key programs, or investigate interesting aspects of professional work.

In general, the structure of a case study research paper is not all that different from a standard college-level research paper. However, there are subtle differences you should be aware of. Here are the key elements to organizing and writing a case study research paper.

I.  Introduction

As with any research paper, your introduction should serve as a roadmap for your readers to ascertain the scope and purpose of your study . The introduction to a case study research paper, however, should not only describe the research problem and its significance, but you should also succinctly describe why the case is being used and how it relates to addressing the problem. The two elements should be linked. With this in mind, a good introduction answers these four questions:

• What is being studied? Describe the research problem and describe the subject of analysis [the case] you have chosen to address the problem. Explain how they are linked and what elements of the case will help to expand knowledge and understanding about the problem.
• Why is this topic important to investigate? Describe the significance of the research problem and state why a case study design and the subject of analysis that the paper is designed around is appropriate in addressing the problem.
• What did we know about this topic before I did this study? Provide background that helps lead the reader into the more in-depth literature review to follow. If applicable, summarize prior case study research applied to the research problem and why it fails to adequately address the problem. Describe why your case will be useful. If no prior case studies have been used to address the research problem, explain why you have selected this subject of analysis.
• How will this study advance new knowledge or new ways of understanding? Explain why your case study will be suitable in helping to expand knowledge and understanding about the research problem.

Each of these questions should be addressed in no more than a few paragraphs. Exceptions to this can be when you are addressing a complex research problem or subject of analysis that requires more in-depth background information.

II.  Literature Review

The literature review for a case study research paper is generally structured the same as it is for any college-level research paper. The difference, however, is that the literature review is focused on providing background information and  enabling historical interpretation of the subject of analysis in relation to the research problem the case is intended to address . This includes synthesizing studies that help to:

• Place relevant works in the context of their contribution to understanding the case study being investigated . This would involve summarizing studies that have used a similar subject of analysis to investigate the research problem. If there is literature using the same or a very similar case to study, you need to explain why duplicating past research is important [e.g., conditions have changed; prior studies were conducted long ago, etc.].
• Describe the relationship each work has to the others under consideration that informs the reader why this case is applicable . Your literature review should include a description of any works that support using the case to investigate the research problem and the underlying research questions.
• Identify new ways to interpret prior research using the case study . If applicable, review any research that has examined the research problem using a different research design. Explain how your use of a case study design may reveal new knowledge or a new perspective or that can redirect research in an important new direction.
• Resolve conflicts amongst seemingly contradictory previous studies . This refers to synthesizing any literature that points to unresolved issues of concern about the research problem and describing how the subject of analysis that forms the case study can help resolve these existing contradictions.
• Point the way in fulfilling a need for additional research . Your review should examine any literature that lays a foundation for understanding why your case study design and the subject of analysis around which you have designed your study may reveal a new way of approaching the research problem or offer a perspective that points to the need for additional research.
• Expose any gaps that exist in the literature that the case study could help to fill . Summarize any literature that not only shows how your subject of analysis contributes to understanding the research problem, but how your case contributes to a new way of understanding the problem that prior research has failed to do.
• Locate your own research within the context of existing literature [very important!] . Collectively, your literature review should always place your case study within the larger domain of prior research about the problem. The overarching purpose of reviewing pertinent literature in a case study paper is to demonstrate that you have thoroughly identified and synthesized prior studies in relation to explaining the relevance of the case in addressing the research problem.

III.  Method

In this section, you explain why you selected a particular case [i.e., subject of analysis] and the strategy you used to identify and ultimately decide that your case was appropriate in addressing the research problem. The way you describe the methods used varies depending on the type of subject of analysis that constitutes your case study.

If your subject of analysis is an incident or event . In the social and behavioral sciences, the event or incident that represents the case to be studied is usually bounded by time and place, with a clear beginning and end and with an identifiable location or position relative to its surroundings. The subject of analysis can be a rare or critical event or it can focus on a typical or regular event. The purpose of studying a rare event is to illuminate new ways of thinking about the broader research problem or to test a hypothesis. Critical incident case studies must describe the method by which you identified the event and explain the process by which you determined the validity of this case to inform broader perspectives about the research problem or to reveal new findings. However, the event does not have to be a rare or uniquely significant to support new thinking about the research problem or to challenge an existing hypothesis. For example, Walo, Bull, and Breen conducted a case study to identify and evaluate the direct and indirect economic benefits and costs of a local sports event in the City of Lismore, New South Wales, Australia. The purpose of their study was to provide new insights from measuring the impact of a typical local sports event that prior studies could not measure well because they focused on large "mega-events." Whether the event is rare or not, the methods section should include an explanation of the following characteristics of the event: a) when did it take place; b) what were the underlying circumstances leading to the event; and, c) what were the consequences of the event in relation to the research problem.

If your subject of analysis is a person. Explain why you selected this particular individual to be studied and describe what experiences they have had that provide an opportunity to advance new understandings about the research problem. Mention any background about this person which might help the reader understand the significance of their experiences that make them worthy of study. This includes describing the relationships this person has had with other people, institutions, and/or events that support using them as the subject for a case study research paper. It is particularly important to differentiate the person as the subject of analysis from others and to succinctly explain how the person relates to examining the research problem [e.g., why is one politician in a particular local election used to show an increase in voter turnout from any other candidate running in the election]. Note that these issues apply to a specific group of people used as a case study unit of analysis [e.g., a classroom of students].

If your subject of analysis is a place. In general, a case study that investigates a place suggests a subject of analysis that is unique or special in some way and that this uniqueness can be used to build new understanding or knowledge about the research problem. A case study of a place must not only describe its various attributes relevant to the research problem [e.g., physical, social, historical, cultural, economic, political], but you must state the method by which you determined that this place will illuminate new understandings about the research problem. It is also important to articulate why a particular place as the case for study is being used if similar places also exist [i.e., if you are studying patterns of homeless encampments of veterans in open spaces, explain why you are studying Echo Park in Los Angeles rather than Griffith Park?]. If applicable, describe what type of human activity involving this place makes it a good choice to study [e.g., prior research suggests Echo Park has more homeless veterans].

If your subject of analysis is a phenomenon. A phenomenon refers to a fact, occurrence, or circumstance that can be studied or observed but with the cause or explanation to be in question. In this sense, a phenomenon that forms your subject of analysis can encompass anything that can be observed or presumed to exist but is not fully understood. In the social and behavioral sciences, the case usually focuses on human interaction within a complex physical, social, economic, cultural, or political system. For example, the phenomenon could be the observation that many vehicles used by ISIS fighters are small trucks with English language advertisements on them. The research problem could be that ISIS fighters are difficult to combat because they are highly mobile. The research questions could be how and by what means are these vehicles used by ISIS being supplied to the militants and how might supply lines to these vehicles be cut off? How might knowing the suppliers of these trucks reveal larger networks of collaborators and financial support? A case study of a phenomenon most often encompasses an in-depth analysis of a cause and effect that is grounded in an interactive relationship between people and their environment in some way.

NOTE:   The choice of the case or set of cases to study cannot appear random. Evidence that supports the method by which you identified and chose your subject of analysis should clearly support investigation of the research problem and linked to key findings from your literature review. Be sure to cite any studies that helped you determine that the case you chose was appropriate for examining the problem.

IV.  Discussion

The main elements of your discussion section are generally the same as any research paper, but centered around interpreting and drawing conclusions about the key findings from your analysis of the case study. Note that a general social sciences research paper may contain a separate section to report findings. However, in a paper designed around a case study, it is common to combine a description of the results with the discussion about their implications. The objectives of your discussion section should include the following:

Reiterate the Research Problem/State the Major Findings Briefly reiterate the research problem you are investigating and explain why the subject of analysis around which you designed the case study were used. You should then describe the findings revealed from your study of the case using direct, declarative, and succinct proclamation of the study results. Highlight any findings that were unexpected or especially profound.

Explain the Meaning of the Findings and Why They are Important Systematically explain the meaning of your case study findings and why you believe they are important. Begin this part of the section by repeating what you consider to be your most important or surprising finding first, then systematically review each finding. Be sure to thoroughly extrapolate what your analysis of the case can tell the reader about situations or conditions beyond the actual case that was studied while, at the same time, being careful not to misconstrue or conflate a finding that undermines the external validity of your conclusions.

Relate the Findings to Similar Studies No study in the social sciences is so novel or possesses such a restricted focus that it has absolutely no relation to previously published research. The discussion section should relate your case study results to those found in other studies, particularly if questions raised from prior studies served as the motivation for choosing your subject of analysis. This is important because comparing and contrasting the findings of other studies helps support the overall importance of your results and it highlights how and in what ways your case study design and the subject of analysis differs from prior research about the topic.

Consider Alternative Explanations of the Findings Remember that the purpose of social science research is to discover and not to prove. When writing the discussion section, you should carefully consider all possible explanations revealed by the case study results, rather than just those that fit your hypothesis or prior assumptions and biases. Be alert to what the in-depth analysis of the case may reveal about the research problem, including offering a contrarian perspective to what scholars have stated in prior research if that is how the findings can be interpreted from your case.

Acknowledge the Study's Limitations You can state the study's limitations in the conclusion section of your paper but describing the limitations of your subject of analysis in the discussion section provides an opportunity to identify the limitations and explain why they are not significant. This part of the discussion section should also note any unanswered questions or issues your case study could not address. More detailed information about how to document any limitations to your research can be found here .

Suggest Areas for Further Research Although your case study may offer important insights about the research problem, there are likely additional questions related to the problem that remain unanswered or findings that unexpectedly revealed themselves as a result of your in-depth analysis of the case. Be sure that the recommendations for further research are linked to the research problem and that you explain why your recommendations are valid in other contexts and based on the original assumptions of your study.

V.  Conclusion

As with any research paper, you should summarize your conclusion in clear, simple language; emphasize how the findings from your case study differs from or supports prior research and why. Do not simply reiterate the discussion section. Provide a synthesis of key findings presented in the paper to show how these converge to address the research problem. If you haven't already done so in the discussion section, be sure to document the limitations of your case study and any need for further research.

The function of your paper's conclusion is to: 1) reiterate the main argument supported by the findings from your case study; 2) state clearly the context, background, and necessity of pursuing the research problem using a case study design in relation to an issue, controversy, or a gap found from reviewing the literature; and, 3) provide a place to persuasively and succinctly restate the significance of your research problem, given that the reader has now been presented with in-depth information about the topic.

Consider the following points to help ensure your conclusion is appropriate:

• If the argument or purpose of your paper is complex, you may need to summarize these points for your reader.
• If prior to your conclusion, you have not yet explained the significance of your findings or if you are proceeding inductively, use the conclusion of your paper to describe your main points and explain their significance.
• Move from a detailed to a general level of consideration of the case study's findings that returns the topic to the context provided by the introduction or within a new context that emerges from your case study findings.

Note that, depending on the discipline you are writing in or the preferences of your professor, the concluding paragraph may contain your final reflections on the evidence presented as it applies to practice or on the essay's central research problem. However, the nature of being introspective about the subject of analysis you have investigated will depend on whether you are explicitly asked to express your observations in this way.

Problems to Avoid

Overgeneralization One of the goals of a case study is to lay a foundation for understanding broader trends and issues applied to similar circumstances. However, be careful when drawing conclusions from your case study. They must be evidence-based and grounded in the results of the study; otherwise, it is merely speculation. Looking at a prior example, it would be incorrect to state that a factor in improving girls access to education in Azerbaijan and the policy implications this may have for improving access in other Muslim nations is due to girls access to social media if there is no documentary evidence from your case study to indicate this. There may be anecdotal evidence that retention rates were better for girls who were engaged with social media, but this observation would only point to the need for further research and would not be a definitive finding if this was not a part of your original research agenda.

Failure to Document Limitations No case is going to reveal all that needs to be understood about a research problem. Therefore, just as you have to clearly state the limitations of a general research study , you must describe the specific limitations inherent in the subject of analysis. For example, the case of studying how women conceptualize the need for water conservation in a village in Uganda could have limited application in other cultural contexts or in areas where fresh water from rivers or lakes is plentiful and, therefore, conservation is understood more in terms of managing access rather than preserving access to a scarce resource.

Failure to Extrapolate All Possible Implications Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings. If you do not, your reader may question the validity of your analysis, particularly if you failed to document an obvious outcome from your case study research. For example, in the case of studying the accident at the railroad crossing to evaluate where and what types of warning signals should be located, you failed to take into consideration speed limit signage as well as warning signals. When designing your case study, be sure you have thoroughly addressed all aspects of the problem and do not leave gaps in your analysis that leave the reader questioning the results.

Case Studies. Writing@CSU. Colorado State University; Gerring, John. Case Study Research: Principles and Practices . New York: Cambridge University Press, 2007; Merriam, Sharan B. Qualitative Research and Case Study Applications in Education . Rev. ed. San Francisco, CA: Jossey-Bass, 1998; Miller, Lisa L. “The Use of Case Studies in Law and Social Science Research.” Annual Review of Law and Social Science 14 (2018): TBD; Mills, Albert J., Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Putney, LeAnn Grogan. "Case Study." In Encyclopedia of Research Design , Neil J. Salkind, editor. (Thousand Oaks, CA: SAGE Publications, 2010), pp. 116-120; Simons, Helen. Case Study Research in Practice . London: SAGE Publications, 2009;  Kratochwill,  Thomas R. and Joel R. Levin, editors. Single-Case Research Design and Analysis: New Development for Psychology and Education .  Hilldsale, NJ: Lawrence Erlbaum Associates, 1992; Swanborn, Peter G. Case Study Research: What, Why and How? London : SAGE, 2010; Yin, Robert K. Case Study Research: Design and Methods . 6th edition. Los Angeles, CA, SAGE Publications, 2014; Walo, Maree, Adrian Bull, and Helen Breen. “Achieving Economic Benefits at Local Events: A Case Study of a Local Sports Event.” Festival Management and Event Tourism 4 (1996): 95-106.

Writing Tip

At Least Five Misconceptions about Case Study Research

Social science case studies are often perceived as limited in their ability to create new knowledge because they are not randomly selected and findings cannot be generalized to larger populations. Flyvbjerg examines five misunderstandings about case study research and systematically "corrects" each one. To quote, these are:

Misunderstanding 1 :  General, theoretical [context-independent] knowledge is more valuable than concrete, practical [context-dependent] knowledge. Misunderstanding 2 :  One cannot generalize on the basis of an individual case; therefore, the case study cannot contribute to scientific development. Misunderstanding 3 :  The case study is most useful for generating hypotheses; that is, in the first stage of a total research process, whereas other methods are more suitable for hypotheses testing and theory building. Misunderstanding 4 :  The case study contains a bias toward verification, that is, a tendency to confirm the researcher’s preconceived notions. Misunderstanding 5 :  It is often difficult to summarize and develop general propositions and theories on the basis of specific case studies [p. 221].

While writing your paper, think introspectively about how you addressed these misconceptions because to do so can help you strengthen the validity and reliability of your research by clarifying issues of case selection, the testing and challenging of existing assumptions, the interpretation of key findings, and the summation of case outcomes. Think of a case study research paper as a complete, in-depth narrative about the specific properties and key characteristics of your subject of analysis applied to the research problem.

Flyvbjerg, Bent. “Five Misunderstandings About Case-Study Research.” Qualitative Inquiry 12 (April 2006): 219-245.

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Opinion | How Putinism Spreads: A Case Study in Georgia

T he citizens of Georgia want to join the European Union, but Russia wants to stop them. Tens of thousands of Georgians gathered in the capital of Tbilisi last week to protest legislation that would silence pro-Western civil society groups. The police responded with tear gas, stun grenades and water cannons, but this attempted crackdown drew even more to the streets.

The ruling Georgian Dream party sparked this political crisis by introducing legislation that would target civil-society groups that receive more than 20% of yearly funding from foreign sources. The U.S. Agency for International Development has provided some $6 billion in aid to Georgia since 1992, while the EU also offers support. The law would impose new disclosure rules and oblige these civic institutions to state they are “pursuing the interests of a foreign power.”

The model is Russia’s foreign agent law, adopted in 2012 as Mr. Putin consolidated power. Russian civic organizations soon faced audits, raids, fines and other harassment that forced many to disband. Georgia’s nonprofits, independent media and civic institutions fear they’ll soon be targeted.

Georgian Dream says the law will improve transparency. But Georgian civil-society groups are already required to disclose extensive details about their finances and operations. Corruption and patronage systems are Soviet-era legacies in Georgia, and support from the U.S. and Europe comes with external transparency requirements to insulate recipients from political pressure.

State Department spokesman Matthew Millersaid last month the U.S. is “deeply concerned” about the new law. But the Kremlin is supportive, which is a giveaway about the law’s purpose. Moscow spreads its influence in Georgia in the shadows and wouldn’t be affected by the new law.

Georgia’s People’s Power party, part of the ruling coalition, introduced similar legislation last year with the support of Georgian Dream. The leaders of People’s Power include prominent opponents of the West. The 2023 effort failed as Georgian nonprofits denounced it as “an onslaught” against “civil society and our democracy” and Georgians protested en masse.

That won’t work this time, warned former Prime Minister Bidzina Ivanishvili, a billionaire who is influential in Georgian Dream. Georgia will hold parliamentary elections in October, and the outcome will influence who becomes president later this year. Under recent reforms, Georgia’s presidency is determined by an electoral college composed of Members of Parliament and local representatives.

In a speech last week, Mr. Ivanishvili said he intends to crack down on his political opponents in the rival United National Movement party. After the elections “the collective” UNM will “get the due punishment it deserves” and “will pay for all the crimes against the Georgian people,” he threatened, according to the Civil.ge, a news website supported by the National Endowment for Democracy.

The Georgian Dream and its allies likely have the votes to pass the foreign-agent legislation and override a veto. But the police response has galvanized protesters. Georgians understand that this is how Putinism spreads, insidiously and in stages, as challengers to the ruling party are stigmatized, prosecuted and harassed as foreign agents.

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Review article, modernizing and harmonizing regulatory data requirements for genetically modified crops—perspectives from a workshop.

• 1 Corteva™ Agriscience, Indianapolis, IN, United States
• 2 CropLife International, Arlington, VA, United States
• 3 BASF Corporation, Research Triangle Park, NC, United States
• 4 Corteva™ Agriscience, Johnston, IA, United States
• 5 Syngenta Seeds LLC, Research Triangle Park, NC, United States
• 6 Bayer Crop Science, Chesterfield, MO, United States

Genetically modified (GM) crops that have been engineered to express transgenes have been in commercial use since 1995 and are annually grown on 200 million hectares globally. These crops have provided documented benefits to food security, rural economies, and the environment, with no substantiated case of food, feed, or environmental harm attributable to cultivation or consumption. Despite this extensive history of advantages and safety, the level of regulatory scrutiny has continually increased, placing undue burdens on regulators, developers, and society, while reinforcing consumer distrust of the technology. CropLife International held a workshop at the 16th International Society of Biosafety Research (ISBR) Symposium to examine the scientific basis for modernizing global regulatory frameworks for GM crops. Participants represented a spectrum of global stakeholders, including academic researchers, GM crop developers, regulatory consultants, and regulators. Concurrently examining the considerations of food and feed safety, along with environmental safety, for GM crops, the workshop presented recommendations for a core set of data that should always be considered, and supplementary (i.e., conditional) data that would be warranted only on a case-by-case basis to address specific plausible hypotheses of harm. Then, using a case-study involving a hypothetical GM maize event expressing two familiar traits (insect protection and herbicide tolerance), participants were asked to consider these recommendations and discuss if any additional data might be warranted to support a science-based risk assessment or for regulatory decision-making. The discussions during the workshop highlighted that the set of data to address the food, feed, and environmental safety of the hypothetical GM maize, in relation to a conventional comparator, could be modernized compared to current global regulatory requirements. If these scientific approaches to modernize data packages for GM crop regulation were adopted globally, GM crops could be commercialized in a more timely manner, thereby enabling development of more diverse GM traits to benefit growers, consumers, and the environment.

1 Introduction

Genetically modified (GM) crops that have been engineered to express transgenes have been commercially cultivated since 1995 and are annually grown on 200 million hectares globally. These crops have delivered important societal benefits, such as increased crop yields, resilience to adverse growing conditions, reduced tillage leading to improved soil health, reduction in the need for crop protection inputs, preservation of natural resources, and improved rural economies ( Klümper and Qaim, 2014 ; Dively et al., 2018 ; Zilberman et al., 2018 ; Smyth, 2020 ; Ala-Kokko et al., 2021 ; Macall et al., 2021 ; Peshin et al., 2021 ; Brookes, 2022a ; Brookes, 2022b ; Brookes, 2022c ). These benefits have led to rapid adoption of GM technology for agricultural production, including 80% of global cotton and 73% of global soybean. One-third of global maize production includes GM traits for herbicide tolerance, insect protection, or both ( AgbioInvestor, 2023 ). GM traits have been introduced in other row crops such as oilseed rape, sugar beet, and alfalfa and, at a smaller scale, in specialty crops such as apples, eggplant, squash and potatoes ( ISAAA, 2020 ). Hundreds of studies have been conducted to assess the safety of GM crops, and there have been no substantiated cases of resulting harm to people or livestock that consume GM crops or to the environment in which they are grown ( European Commission, 2010 ; Snell et al., 2012 ; Van Eenennaam and Young, 2014 ; NASEM, 2016 ).

Despite this track record of safety and benefits, regulatory data requirements for approval and commercialization of GM crops have continued to grow globally. GM technology is primarily limited to major global crops, like maize and soybean, and to major input traits, such as insect protection and herbicide tolerance. While there are many efforts underway to use GM technology for other traits and to improve minor crops, especially for small holders in the developing world ( David, 2009 ; Shelton, 2021 ; Woodruff, 2024 ), securing the regulatory approvals to enable cultivation and avoid potential trade disruptions can present often insurmountable challenges to commercialization. Only a few large multinational developers can afford the US$115 million cost and also persist for the 16 years that it currently takes, on average, to bring a new trait to the global market. More than one-third of those costs, and more than one-half of that time, are taken by the regulatory process ( AgbioInvestor, 2022 ). These extensive and complex regulatory systems also mean that governments must invest significant resources in developing and maintaining regulatory bodies staffed with sufficient people and expertise, creating a burden on taxpayers and society. Countries that cannot afford such an investment are missing out on the benefits of GM crops.

CropLife International and its member companies that develop GM crops (BASF, Bayer Crop Science, Corteva™ Agriscience, and Syngenta) have proposed a modernized regulatory framework and streamlining of data requirements for GM crops that is based on scientific rationale and builds on the 25 years of experience with the technology, and the history of its safe use ( Mathesius et al., 2020 ; Anderson et al., 2021 ; Bachman et al., 2021 ; Brune et al., 2021 ; Goodwin et al., 2021 ; McClain et al., 2021 ; Roper et al., 2021 ; Waters et al., 2021 ). The development of the proposed framework was motivated and guided by considering four key questions. 1) Are today’s regulations for GM crop approvals risk-proportionate? 2) Do today’s data requirements act as an unnecessary barrier to beneficial innovation? 3) How can knowledge and experience accumulated over the last 25 years inform modernization of regulations? 4) Can data requirements be streamlined and harmonized across countries and authorities? These questions were used to guide the determination of the types of data that are necessary to ensure GM crops are developed and deployed without increased risks for food and feed safety or the environment compared to conventional crops. Under this framework, core data, which are important for the problem formulation step of the risk assessment of the GM crop, were identified. The core data are used for problem formulation to identify plausible cause-and-effect hypotheses of harm from the GM crop. Depending upon the outcome of the problem formulation for a specific crop by trait combination, additional supplementary (i.e., conditional) studies may be needed, on a case-by-case basis, to analyze any plausible risk identified. Figure 1A outlines proposed core and supplemental studies for a Food and Feed Safety Assessment; Figure 1B outlines proposed core and supplemental studies for an Environmental Risk Assessment. CropLife International took an approach that is consistent with principles of risk assessment such that the proposed data requirements can fully inform decision-making by a regulatory agency, without the extraneous data present in many current regulatory submissions that does not meaningfully contribute to the risk assessment of the GM crop.

Figure 1 . (A) proposes a set of data recommended for a science-based food and feed safety assessment for a typical GM crop and considers as core studies: basic molecular characterization, protein characterization and expression, and protein safety (i.e., history of safe use of the protein and source organism and bioinformatics to identify potential toxins and allergens). The outcomes of these core data are used to inform the problem formulation step and decide, on a case-by-case basis which, if any, supplementary studies are needed to make a conclusion on safety ( Brune et al., 2021 ; Waters et al., 2021 ). (A) is adapted from Brune et al., 2021 and Waters et al., 2021 . (B) proposes a set of data recommended for a science-based environmental risk assessment for a typical GM crop and considers as data: understanding the receiving environment and the basic biology of the unmodified plant; assessing the agronomic similarity of the GM crop to its conventional counterparts (i.e., agronomic comparative assessment); and understanding the intended trait of the GM plant and assessment of how the intended trait may lead to environmental harm. The core data should be used first to inform the problem formulation. If a conclusion cannot be made about the pathway to harm using the core data, additional case-by-case hypothesis-driven supplementary studies should be considered ( Anderson et al., 2021 ).

To further examine whether CropLife International’s proposed modernized data requirements are sufficient for food and feed safety assessments and for environmental risk assessments, a workshop was held at the 16th International Society of Biosafety Research (ISBR) Symposium (St. Louis, USA) in 2023. Using a case study of a hypothetical GM maize event containing two familiar transgenic traits (herbicide resistance and insect protection). The workshop participants were charged with considering whether the proposed data in the case study are scientifically both necessary and sufficient to determine the food, feed and environmental safety of the hypothetical GM crop.: CropLife International member representatives that served as moderators during the workshop authored this publication to report the outcomes and summarize the discussions that took place among the participants. The participants varied in their backgrounds and prior experience with risk assessment and included individuals from regulatory agencies, technology developers, consultant groups, and academia. A wide range of geographical areas were represented.

2 Case study description

For the case study, a hypothetical GM maize event was presented to the workshop participants for evaluation. The hypothetical event was intentionally simple for this exercise (i.e., a familiar crop with traits that are similar to many transgenic events that have already been reviewed and approved by regulatory agencies globally, with several in commercial production for many years), which enabled the participants to analyze in greater depth the need for data that is routinely submitted but may not contribute to the safety assessment. More specifically, a maize ( Zea mays ) event containing a single insertion encoding for two proteins from a single T-DNA introduced using standard disarmed Agrobacterium tumefaciens-based transformation was described. The two hypothetical traits provide protection against lepidopteran pests and tolerance to treatment with glyphosate herbicide, using a hypothetical Cry1 protein from Bacillus thuringiensis ( Bt ) and a hypothetical EPSPS protein variant isolated from maize, respectively. The workshop participants were asked to separately consider a food and feed safety assessment or an environmental risk assessment for this same hypothetical GM maize event. Additional distinctions between the presentation of the case study for the different assessments are outlined below.

2.1 Food and feed safety assessment

For the Food and Feed Safety Assessment, the results from hypothetical evaluations of core data on the characterization and safety assessment of the event were provided (summarized in Table 1 ). Throughout this paper, the term ‘data’ refers to both the results of experiments or studies as well as information gathered from literature reviews, consensus documents and other similar sources. As described in Waters et al. (2021) , the core data for a food and feed safety assessment are: 1) molecular characterization, 2) protein characterization, and 3) protein safety (allergenicity and toxicity). The results of the molecular characterization demonstrated that there was an insertion of a single T-DNA sequence into the maize genomic DNA without any vector backbone sequences. There were no changes in the intended protein coding sequence and constitutive expression of both proteins were driven by familiar promoter elements (35S from cauliflower mosaic virus and ubiquitin promoter from Zea mays , respectively). Finally, the inserted DNA and the traits were indicated as being stable over three generations. The protein characterization data given to participants indicated that the molecular weight and amino acid sequence were as expected for both proteins. The function of the hypothetical Cry1 protein was established as having activity limited to target lepidopteran pest species, with no activity against other insect orders. Field tolerance to glyphosate from the hypothetical EPSPS protein variant was also as expected. The protein safety data indicated that both proteins are similar to proteins that have a history of safe use for food and feed; neither EPSPS proteins nor Cry proteins have any known toxicity or allergenicity concerns. Bioinformatics analysis comparing the amino acid sequences of both hypothetical proteins to a protein database also demonstrated that neither protein is related to any protein of toxicological concern nor related to any allergens in the qualified allergen database.

Table 1 . Summary of food and feed safety assessment core data of the hypothetical GM maize.

A familiar crop with familiar traits and minimal genetic disruptions was used for the workshop to promote discussion of what data is really needed to establish the food and feed safety of a GM crop event. It was also noted to workshop participants that extensive protein expression data in the plant was not obtained, nor was detailed proximate or nutrient composition data included. Further, while it was established that bioinformatics confirmed no homology to known allergens or toxins, no exposure assessments, no animal feeding studies, or other more direct assessments of potential for harm from the hypothetical event were included. As presented, the case study stated that considering 1) the assessment from the core data, 2) the familiarity of the crop and traits, and 3) the lack of direct interaction with other metabolic pathways of the plant, there was no hypothesis of food and/or feed safety risks for the new GM maize crop, and therefore additional supplementary data are not warranted to establish food and feed safety, in accordance with the approach established in Brune et al. (2021) , McClain et al. (2021) and Roper et al. (2021) .

2.2 Environmental risk assessment

For Environmental Risk Assessment (ERA), the intention of the case study was to model how problem formulation and core data should be leveraged to inform ERA of a GM crop for cultivation safety. Problem formulation is a process used in the ERA to develop plausible pathways to harm resulting from cultivation of the GM crop. Problem formulation first considers core data, then considers other data on a case-by-case basis if it is deemed necessary to inform the risk assessment. For ERA, core data includes information related to the receiving environment, description of basic biology of the unmodified plant, assessment of the agronomic similarity of the GM crop to its conventional counterparts, and characterization of the intended traits of the GM crop (summarized in Table 2 ). For the purpose of the case study, the protection goal was broadly stated as protection of biodiversity, specifically protection of beneficial or charismatic species. For the purposes of the workshop, the core characteristics of the event as described for the food and feed assessment were considered the same (e.g., molecular features), with additional information focused on agronomic and environmental aspects provided to guide the ERA discussion.

Table 2 . Summary of environmental risk assessment core data.

The participants were presented with the following set of core data (summarized in Table 2 ) and were asked to consider if a plausible pathway to harm could be developed related to weediness, invasiveness, gene flow to wild relatives or hazard to non-target organisms: 1) assessment of the receiving environment indicating no wild relatives of maize present in the cultivation country and no changes to the standard agronomic practices relative to non-modified maize; 2) assessment of the basic biology of maize, using consensus documents, demonstrating non-modified maize has no weediness characteristics and requires human intervention for propagation and survival; 3) multilocation field trial data demonstrating hypothetical maize was agronomically similar to non-modified maize; and 4) assessment of the intended phenotype (i.e., insect protection and herbicide tolerant traits are not intended to increase fitness or survival in the environment).

Based on the core data assessed, the case study proposed that there are no plausible hypotheses for how cultivation of the hypothetical maize could result in environmental harm related to weediness, invasiveness, and gene flow to wild relatives. Thus, additional data will not further contribute to meaningful assessment of environmental safety. However, the case study proposed that a plausible pathway to harm to non-target organisms could be developed based on the intended insect protection phenotype. The hypothetical Cry1 protein was presented as providing protection against specific lepidopteran insect pests (European corn borer, Asian corn borer, Southwestern corn borer, corn earworm, and fall armyworm).

The mode of action of Cry proteins in GM crops is well-documented ( Bravo et al., 2007 ; OECD, 2007 ). In this case study, additional supplemental protein expression data and non-target organism hazard data were provided to the participants, and they were asked to consider if additional plausible pathways to harm could be developed. The set of supplemental data (summarized in Table 3 ) was as follows: 1) multilocation field trial data measuring the concentration of the hypothetical Cry1 protein in several plant tissues to inform exposure assessment; 2) an exposure assessment for different non-target organisms to consider the likelihood and magnitude of exposure to the hypothetical Cry1 protein; and 3) results of non-target organism Tier I hazard studies for several surrogate species representing different taxonomic orders (e.g., ladybird beetle, a soil dwelling organism, and a non-target predator) conducted with the Cry1 protein in the diet.

Table 3 . Summary of environmental risk assessment supplementary data.

The multilocation field trial data showed that the Cry1 protein was only detectable (above the limit of detection) in the leaf and whole plant, with the highest concentration found in R1 leaf. The protein was below the limit of detection of the analytical assay in pollen and root. Based on the tissue expression, the exposure assessment concluded that since there is no expression of the Cry1 protein in pollen, there would be no route of exposure to non-target pollen feeding organisms (e.g., honeybee). Finally, the Tier I hazard studies indicated that no hazard was observed at concentrations that exceeded >10x the expected environmental concentration.

Usually, the assessment of adverse effects in non-target organisms follows a tiered approach that starts with laboratory studies at levels that exceed worst-case exposure conditions ( Romeis et al., 2011 ). Tier I laboratory studies with non-target organisms are typically conducted using at least 10X the worst-case expected environmental concentration. In this case, the results of the hypothetical Tier I dietary studies indicated no hazard (i.e., adverse effects) at concentrations that exceeded 10x the worst-case expected environmental concentration, and thus a conclusion that evidence is sufficient without conducting additional hazard testing was indicated. Based on data from the exposure assessment and non-target hazard assessment studies, the case study proposed that there were no plausible pathways to harm to non-target organisms due to lack of exposure and/or lack of risk because there were no adverse effects at concentrations that exceeded 10X the worst-case expected environmental concentration. Participants were asked to consider whether they agreed with the conclusions proposed by the case study based on core data and additional supplementary data related to protein expression, non-target organism exposure, and non-target organism hazard.

Additional information such as molecular data to confirm that the insert is an intact single copy, stable across generations, and that there is no insertion of DNA from the plasmid backbone were not provided in the ERA case study. These additional data for product characterization have historically been submitted to regulators as part of cultivation applications, but they are not directly relevant to ERA ( Anderson et al., 2021 ).

3 Learnings from breakout group discussions

After participants attended the introductory presentation session of the workshop, they were distributed into smaller discussion groups of approximately 10 people, with CropLife International member representatives serving as moderators. Each participant had the opportunity to choose either the Food and Feed Safety Assessment or the Environmental Risk Assessment, depending on their respective areas of interest.

The goal of the smaller group discussion sessions was to allow participants to go into deeper conversations about the proposed modernized paradigm for a risk assessment of a GM crop. Discussions were aided by a distribution of a printed booklet that included a description of the hypothetical GM maize event and the data collected, and that outlined the key concepts of using the core data for a Food and Feed Safety Assessment and Environmental Risk Assessment. Moderators provided some time for the participants to review the information and then introduced the case study by giving a brief overview of the information provided in each data section of the case study. Participants were encouraged to provide feedback and to bring up questions and/or comments about topics/elements of the case study that they considered not sufficiently covered by the data provided. They were also asked to complete a worksheet allowing for comments on the specific steps of the assessment process.

Discussions during this small group session were productive and highly informative. Overall, the participants were engaged, willing to discuss, and mostly supportive of the general assessment framework of primarily using core data and only using further assessments on a case-by-case basis.

A summary of key points from the breakout group discussions is shared below. This section is not intended to be a complete summary of the discussion, rather the authors have captured points of interest with an emphasis on points that are worth considering for future workshops and discussions on this topic.

3.1 Food and feed safety assessment

In the small group session, participants were asked to consider 1) the assessment from the core studies (see Table 1 ), 2) the familiarity of the crop and traits, and 3) the lack of direct interaction with other metabolic pathways of the plant, and then decide whether there was a hypothesis of food and/or feed safety risks for the new GM maize crop. Because of these considerations, the position for the case-study was that, for the hypothetical event, additional supplemental studies are not warranted to establish food and feed safety, and the participants discussed whether they agreed with this position.

Below are some key feedback and questions captured during the workshop regarding the proposed approach for the assessment of Food and Feed Safety of the hypothetical GM maize event.

3.1.1 Molecular characterization (transformation method, transformation construct, DNA insert characterization)

Overall, the participants agreed that the proposed molecular characterization core data is aligned with what is currently provided and that the information was sufficient to inform a food and feed safety assessment. One potential exception to the core data package that was discussed is data demonstrating that the insert is stable over at least three generations. The participants suggested that this study could be considered as supplemental, and not necessarily required as part of the core data package, if the insert is demonstrated to be inserted into the chromosome and is not interrupting endogenous genes or regulatory elements, and there is no other reason to expect that the insert might be unstable (e.g., insertion site near a transposon). There was some discussion that three generations of data may not be considered enough by all regulatory agencies and that additional generations could be required for polyploid crop species. Additionally, participants raised questions about Agrobacterium transformation not being targeted and discussed providing data on whether any internal genes were modified. It was also noted by workshop participants that the use of Next-Generation Sequencing (NGS) to characterize the insert is not yet accepted by all regulatory agencies, but also there was recognition of the utility of NGS to provide a more comprehensive characterization of the insert and the insertion site compared to traditional methods (e.g., Southern blots).

3.1.2 Protein characterization (molecular weight, protein sequence confirmation, protein function)

Participants agreed that the protein characterization information was sufficient to inform the food and feed safety assessment, with some discussions around whether a registrant would always be able to provide what is required, as some proteins may be more challenging to characterize (e.g., difficulties in isolating the proteins in an active form, generating specific antibodies, or generating SDS-PAGE and Western blot data). A question was also raised on maize codon optimization and if the protein would still be considered the same as the native version. Future workshops can reinforce that maize codon optimization of the GM trait gene does not alter the trait protein sequence. Thus, it should not change the safety profile of the protein if there is no change to the amino acid sequence. Discussion also occurred regarding familiarity with promoters and the relationship to expression levels. The participants discussed if there might be a need to better understand the protein expression levels for unfamiliar promoters and also if increased expression levels might raise a concern of potentially increased allergenicity risk.

3.1.3 Protein safety/toxicology/allergenicity (background, source, history of safe use, bioinformatics)

Participants agreed that the EPSPS protein information for safety was sufficient to inform the food and feed risk assessments, but questions were raised about Cry proteins around digestibility and heat stability. There was also discussion regarding how similar a protein would need to be to a known protein to be considered familiar. Additionally, concerns were raised in the small group discussion on the limited protein expression data provided in the case study as it related to an exposure assessment. In response, the moderators noted that an exposure assessment is not necessary, because no hazard was identified from the proteins. However, when a hazard is identified, then protein expression levels are needed to enable assessment of potential exposure ( Brune et al., 2021 ).

3.1.4 Additional information needed to determine event safety

It was stated by one participant that if there was a disruption of a native gene, then composition data could be requested. Discussion also occurred regarding the concept of History of Safe Use (HOSU), and the amount of data, time and similarity (e.g., consideration of minor protein sequence differences) needed to establish something as having sufficient familiarity to be considered safe without additional data. One participant suggested that protein sequence data would be needed to demonstrate a HOSU and could be useful in determining the activity of the protein.

3.1.5 General feedback for food and feed safety assessment

Although participants generally agreed that the case study with a familiar crop and familiar traits is a good starting point for the discussions, several suggestions were made for further discussions to also provide a case study on an unfamiliar event or protein, to lay out how each study informs the safety assessment, to provide more on the problem formulation process, and to provide more graphics and to use examples. Discussion also occurred around the challenges of communicating and making changes to the currently provided data in regulatory applications. On this topic, proposals from participants included suggestions to emphasize more the end goal of getting needed products on the market sooner with less regulatory burden for all stakeholders and to publish more data prior to submission of the application in the scientific literature, and to be ready to provide additional data upon request.

3.2 Environmental risk assessment

After introducing the case study, the CropLife International moderator described a list (provided with the case study) of the specific potential pathways to harm that are relevant to the cultivation of the hypothetical maize event. Additionally, an explanation for how the core data can be used to sufficiently assess environmental risk was provided. For plausible pathways to harm that may not be sufficiently addressed by the core data (i.e., potential harm to non-target organisms), another list of potential pathways to harm that are specific to non-target organism (NTO) exposure was also presented.

Below are some key feedback and questions captured during the workshop regarding the proposed approach for the Environmental Risk Assessment of the hypothetical GM maize event.

3.2.1 Weediness potential

There was an overall consensus among the workshop groups that weediness can be adequately assessed using only core data. Participants agreed that there is not a plausible pathway to harm in the case study since maize is highly domesticated and volunteers will not survive without human intervention and management. One group discussed questions around the potential for dormancy, which may be a weediness trait, and whether it can be assessed in the core data (multilocation field trial; Table 2 ). It was concluded within the groups that the similarity in agronomic characteristics between the GM maize event and the non-GM maize in the case study core data is sufficient to show that there is a highly unlikely risk of weediness potential. This follows the principle of placing risk in the context of current practice (i.e., that the modified maize will have no greater risk than that of cultivation of the non-modified maize) ( Raybould and MacDonald, 2018 ). However, one workshop group had unresolved discussions on whether a difference in agronomic performance between different geographical regions may result in differences in the risk assessment and what specific agronomic elements are the most relevant to consider. Some participants in this group proposed scenarios in which the agronomic data generated in field trials performed outside of the cultivation country may not sufficiently represent the agronomic outcomes of field trials performed within the cultivation country.

3.2.2 Gene flow potential to wild relatives

There was general consensus that there is no environmental safety concern of gene flow in the case study based on the core data because there were no wild relatives present in the hypothetical cultivating environment. There was some interest from participants in further exploring how the risk assessment and data requirements will change if the cultivation environment did contain wild relatives. Also, there was some discussion on the threshold of relatedness between the GM maize and a wild relative species that constitutes a safety concern in terms of gene flow. Ultimately, there was additional consensus that product registrants should demonstrate that there are no wild relative species that are reproductively compatible with GM maize (regardless of species relatedness) to position that there is no gene flow concern. Alternatively, if there are wild relative species in the area of cultivation an assessment of the likelihood and consequences of trait introgression into the wild relative population may be warranted based on a problem formulation approach ( Anderson et al., 2021 ). Participants generally stressed the importance of citing published literature (e.g., accepted consensus references on crop-specific biology) as part of the core data to support the environmental risk assessment. Although it was acknowledged that gene flow will not likely occur between GM maize and wild relatives in the case study example, there was some discussion around whether gene flow may occur between the GM maize and adjacent local non-GM maize varieties and negatively impact crop integrity and biodiversity. The case study focused on assessing plausible pathways to harm related to gene flow between GM maize and sexually compatible weedy relatives. Future workshops can address concerns that were raised about coexistence of GM and non-GM cropping systems. Such a workshop may have to distinguish between environmental risks and market or socio-political concerns. For example, countries that have landrace populations for which the genetic make-up per se is a protection goal may have societal concerns about coexistence (for example, there could be changes the genetic identity of the landrace).

3.2.3 Plausible pathways to harm for non-target organisms (NTO)

All groups aligned that the only plausible pathway to harm from the case study that could not be sufficiently addressed with core data alone was the potential for harm to NTOs from potential exposure to the hypothetical Cry1 protein ( Table 2 ). Participants discussed the plausible pathways to harm that are specific to NTOs. There was general agreement that no additional data was needed to assess the potential for the EPSPS protein conferring the herbicide tolerance trait to cause harm to NTOs. However, participants acknowledged that public perception of herbicide tolerance traits could influence regulatory decisions and may need to be considered when determining the registrability of a GM crop. Such perceptions are not reflective of an actual risk, and the additional data generated do not inform the science-based risk assessment. For other pathways to harm, there was consensus that if there was either no hazard or no detectable exposure, then there is low risk to NTOs. For example, honeybees that may directly consume maize pollen and NTO lepidopterans that may indirectly consume maize pollen that drifts onto their host plants should have low risk in the ERA case study since the GM maize event has expression less than the limit of detection (LOD) of the insecticidal protein in pollen tissue ( Table 2 ). It was generally accepted by workshop participants that if expression of the insecticidal protein is <LOD in tissues that might be consumed by an NTO, further toxicity testing to determine hazard is not warranted.

Participants were also mostly aligned that aquatic environments generally experience minimal exposure to GM crop tissue and so additional toxicity testing is not needed for aquatic NTO species in most situations. However, some participants expressed uncertainty on whether this may be an issue if GM crops are cultivated very close to aquatic environments, which may affect exposure levels to NTO aquatic species. For NTO species where there is a plausible pathway to harm, all groups agreed that further data (exposure assessment or NTO Tier I laboratory testing) might be needed. Some discussions among participants regarding appropriate surrogate species to use for NTO testing and to what extent test species need to match those found in the cultivation regions were not resolved in the workshop. There was some additional discussion around the large body of scientific literature describing the surrogate species concept for testing Cry proteins and other types of plant incorporated protectants (e.g., Romeis, et al., 2011 ; Romeis et al., 2013 ; Bachman et al., 2021 ). While the terms “focal species” and “indicator species” were not discussed directly as part of the workshop, understanding protection goals and selecting appropriate surrogate species or indicator species to inform the science-based assessment of risk is an important consideration ( Rose, 2007 ; Roberts et al., 2020 ). Despite the lack of consensus on species selection, there was clear alignment among participants that NTO species representatives should only be tested if there is a valid hypothesis that there is a plausible pathway to harm for that specific organism type. For this reason, NTO studies should only be conducted when hypothesis-driven ( Figure 1B ).

3.2.4 General feedback and future considerations for ERA

Although participants agreed that a generic ERA case study is a good starting place, participants indicated that future workshops using a modified case study tailored for specific geographical regions will be even more helpful. As different countries have different sets of questions and concerns from local regulatory agencies, using more country-specific scenarios and less familiar pest-control traits in a case study may be more directly relevant in that region.

Related to gene flow, there was not a consensus about potential for harm in small team discussions. Future workshops would benefit from guided discussion to help develop problem formulation for gene flow. For example, it could be established as a baseline that for gene flow to occur naturally in the environment, and when assessing the potential for harm from gene flow between GM maize and local maize varieties, it should be compared to potential for harm from gene flow of non-GM maize and local maize varieties ( OECD, 2023 ). Furthermore, future workshops can reinforce that if gene flow to local maize varieties is a relevant concern for a specific cultivation country, then there is a large body of literature to leverage to assess if additional data is needed to inform the risk assessment (See OECD, 2023 Annex B for recent review) such a workshop would need to distinguish between the true environmental impact and concerns related to trade or economic issues.

Also, there were productive discussions on the topic of data transportability. Participants generally accepted the concept of transportability for lab study data. However, due to a lack of time for discussion, some unresolved questions remained regarding the transportability of field study data. Future workshops will benefit from guided discussion to help explain the principle of data transportability. An underlying principle of data transportability is that if no biologically relevant differences between a GM crop and its conventional counterparts are observed in one country or region, data from these studies can be used to inform the risk assessment in another country, regardless of agroclimatic zone ( Bachman et al., 2021 ). Following the recommendations for modernizing global regulatory frameworks for GM crops, additional agronomic data should only be collected in the local environment if there are plausible pathways for harm that cannot be fully informed by the core data.

Furthermore, there was some interest from participants in discussing how the proposed risk assessment paradigm might apply to combined GM products (i.e., breeding stacks), yield and stress traits (e.g., drought resistance), and streamlining of import registrations.

One topic that generated discussion across groups was the value of product characterization data in an environmental risk assessment. In the proposed modernized regulatory framework ( Anderson et al., 2021 ), underlying characterization data for the GM event are not regarded as core to the regulatory assessments (such as molecular data to confirm that the insert is an intact single copy, stable across generations, and that there is no plasmid backbone DNA). Although these data do not directly inform the ERA ( Anderson et al., 2021 ), it was discussed that an understanding of the characteristics of the GM product provides foundational information that enables the regulatory assessments to focus on the intended introduced trait during the problem formulation stage. Therefore, it was proposed to consider including, as part of the modernized ERA framework, a set of foundational information and data from the characterization of the GM event that confirms that (1) the intended gene sequence was inserted and functions as intended, as well as the number of such insertions; (2) the plants produce the intended newly expressed protein (NEP); (3) the intended phenotype is achieved.

4 Key considerations and takeaways from the workshop

The case study for the workshop considered a single event, albeit one that contained genetic material encoding for two proteins leading to two distinct traits (herbicide tolerance and insect protection). However, the majority of commercialized products contain multiple GM events that are combined through conventional breeding (also known as stacked trait products). The typical regulatory process first assesses all single events, before applying regulatory processes, if any, to the stacked trait products. In this sense, the case study used for the workshop reflected a realistic scenario in which regulators assess a single event regardless of whether the event will be commercialized as a single event or as a stacked trait product.

Regulatory processes for stacked trait products vary globally, with many countries recognizing the long, safe history of conventional breeding and not requiring additional assessment once all the single events are approved. It is the position of CropLife International that additional safety assessment of a stacked trait product produced by conventional breeding should not be required unless there is a plausible and testable hypothesis for interaction of the traits ( Goodwin et al., 2021 ). This case study did not address stacked trait products however, further iterations could include consideration of stacked trait products and how to evaluate possible interaction of traits.

The workshop was convened to explore the proposed modernized data requirements for regulatory assessments of GM crops ( Anderson et al., 2021 ; Waters et al., 2021 ). The participants were charged with considering whether currently implemented regulations for GM crops are risk-proportionate or whether they create an unwarranted barrier to the introduction of new traits. The organizers presented a position that knowledge and experience from 25 years of research and development could inform regulatory modernization and that streamlined data requirements could advance harmonization across countries and authorities.

Overall, considering the case study discussed, the participants at the workshop found the proposed modernized data requirements generally to be necessary and sufficient for decision making to support the safe commercial introduction of a new GM crop. There was a clear consensus that some of the current data requirements are no longer routinely warranted for familiar traits such as that discussed in the case study, given the track record of GM crops not presenting unexpected or unintended effects on food or feed safety or environmental risk relative to their conventional counterparts. Participants appreciated the benefit of harmonized hypothesis-based risk assessments to enable future deployment of GM crops that can address emerging agricultural challenges associated with increasing demand for affordable healthy food and changing agricultural environments. The points discussed in this publication will be used to further clarify recommendations for supplementary case-by-case data and guide the development of future, more targeted workshops and related discussions. In particular, applying the proposed framework to traits and crops with which there is less familiarity and established HOSU than those used in the case study may be associated with greater uncertainty in the foundational information of the GM event. Additional case studies involving less familiar traits and different crops should be used to further test the robustness of the modernized regulatory framework.

The workshop focused on what data was scientifically necessary and sufficient to make a conclusion on the food, feed and environmental safety of the GM crop. However, several participants noted that certain data not included in the case study was either required in their jurisdiction or routinely submitted by applicants. While it was beyond the scope of this workshop, future targeted workshops or symposia could address the extent to which regulatory authorities have the flexibility to decide, on a case-by-case basis, what data is necessary to make a conclusion on safety. In some jurisdictions the recommendations of the modernization project could be implemented by applicants by including a scientific rationale in their submission for why a specific study is not necessary. In other cases, changes to laws, regulations, or written guidance would be needed to implement these recommendations.

The case study for the first workshop, as described in this publication, was a valuable tool to foster discussion about science-based data requirements for the assessment of GM crops. If these scientific approaches to modernize data packages for GM crop regulation were adopted globally, delays to the commercialization of GM crops could be reduced, thereby allowing farmers access to new GM traits that will benefit not just growers, but consumers and the environment as well. For more information on the case study used in the workshop, or if there is interest in hosting a similar workshop, please contact the corresponding author.

Author contributions

NS: Conceptualization, Writing–original draft, Writing–review and editing. AS: Conceptualization, Writing–original draft, Writing–review and editing. JS: Writing–original draft, Writing–review and editing. JA: Writing–original draft, Writing–review and editing. MH: Writing–original draft, Writing–review and editing. DM: Writing–original draft, Writing–review and editing. CM: Writing–original draft, Writing–review and editing. MS: Writing–original draft, Writing–review and editing. SS: Writing–original draft, Writing–review and editing. EU-W: Writing–original draft, Writing–review and editing.

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. CropLife International supported the open access publication of this work. The funder was not involved in the writing of this article, or the decision to submit it for publication.

Conflict of interest

Authors NS, JA, and CM were employed by Corteva™ Agriscience. Author AS was employed by CropLife International. Authors JS and MS were employed by BASF Corporation. Authors MH and SS were employed by Syngenta Seeds LLC. Authors DM and E-UW were employed by Bayer Crop Science. BASF Corporation, Bayer Crop Science, Corteva™ Agriscience, and Syngenta Seeds LLC are commercial developers of GM crops.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

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Keywords: genetically modified (GM), regulation, food and feed, safety assessment, environmental risk assessment (ERA), problem formulation, cultivation, data requirements

Citation: Storer NP, Simmons AR, Sottosanto J, Anderson JA, Huang MH, Mahadeo D, Mathesius CA, Sanches da Rocha M, Song S and Urbanczyk-Wochniak E (2024) Modernizing and harmonizing regulatory data requirements for genetically modified crops—perspectives from a workshop. Front. Bioeng. Biotechnol. 12:1394704. doi: 10.3389/fbioe.2024.1394704

Received: 02 March 2024; Accepted: 12 April 2024; Published: 10 May 2024.

Reviewed by:

Copyright © 2024 Storer, Simmons, Sottosanto, Anderson, Huang, Mahadeo, Mathesius, Sanches da Rocha, Song and Urbanczyk-Wochniak. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Abigail R. Simmons, [email protected]

This article is part of the Research Topic

Advancing Science in Support of Sustainable Bio-Innovation: 16th ISBR Symposium

• Open access
• Published: 06 May 2024

Barriers to implementing problem-based learning at the school of medicine of Debre Berhan University, Ethiopia

• Aklile Semu Tefera 1 ,
• Ermiyas Endewunet Melaku 2 ,
• Besufekad Mulugeta Urgie 2 ,
• Erzik Muhammed Hassen 2 ,
• Tilahun Deresse Tamene 3 &
• Enguday Demeke Gebeyaw 1  

BMC Medical Education volume  24 , Article number:  501 ( 2024 ) Cite this article

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Metrics details

Implementing PBL in teaching and learning can be challenging due to a variety of complex barriers. Studies on barriers to the implementation of problem-based learning in Ethiopia are scarce. This study aimed to explore the barriers to the implementation of problem-based learning at the Debre Berhan University Medical School.

A qualitative study was conducted among faculty and medical students at the medical school. Purposive sampling was used to select participants. Semi-structured interviews were conducted with tutors and academic leaders, including the problem-based learning coordinator, the biomedical sciences coordinator, and the school dean. Data was also collected from students through focus group discussions. All interviews and discussions were recorded. The four steps of data analysis of Spradley, including domain analysis, taxonomic analysis, componential analysis, and theme analysis, were employed.

The study identified student-related, tutor-related, case scenario-related, and assessment-related barriers as the most significant obstacles to implementing problem-based learning. These barriers included work overload for both students and tutors, lack of training and experience among tutors, student reluctance, absence of standardized case scenarios, subjectivity of assessment methods, and on-the-spot assessment of students.

Conclusions and recommendations

: Lack of both tutor and student commitment, lack of standardized cases, absence of a recognition of staff input, gap in communication skills, work overload, lack of continuous training, and at-spot evaluation of students were identified as the main barriers to the implementation of PBL.

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Introduction

Problem-based learning (PBL) is an instructional approach in which students work together in small groups, guided by a tutor, to solve problems and reflect on their experiences [ 1 ]. In this process, the learners, rather than the tutor, are active participants in the discussion, and each member of the group contributes to the learning. The PBL tutor is a facilitator and evaluator who provides feedback to the group. A case is usually discussed over two tutorials, each two hours duration. At the end of the first tutorial, the students identify learning goals that guide their self-directed learning [ 2 , 3 ].

Compared to conventional curriculum, PBL is reported to have many advantages, including increased knowledge retention, improved problem-solving abilities, and better integration of basic science and clinical skills. Additionally, it has been assumed that the PBL approach promotes the utilization of social learning principles, which activates group discussion and therefore contributes to the development of interpersonal communication and presentation skills [ 4 , 5 , 6 ].

The evident benefits of PBL and the changing face of medicine and medical education have led many institutions to consider the adoption of PBL curricula [ 7 ].The introduction of PBL as part of the medical education curriculum has a relatively short history in Ethiopia. It was adopted as an educational strategy in the innovative medical education curriculum of 2011, which has been implemented in 13 medical schools of the country [ 8 ]. Debre Berhan University Medical College was one of those medical schools who adopted PBL as one of the key educational methods in 2011. Currently, it has been introduced in many other Ethiopian medical schools.

The program is designed for preclinical medical students. Teachers usually undergo two to three days of training before being assigned as tutors, although this training is not provided consistently. Each week, students engage in a problem-based learning (PBL) session based on a single case scenario, spanning two nonconsecutive days. On the first day, students receive the scenario of the case and study objectives and references, allowing them time to review the case. A detailed discussion will take place during the next session.

Despite its benefits, implementing PBL poses complex challenges in medical education. Research across developed and developing nations highlighted barriers including limited resources, questioning techniques, delayed facilitator responses, unawareness of individual learning goals, time demands for both teachers and students, large class sizes, information overload, low motivation, anxiety, lack of technology, and the unfamiliarity with PBL among traditional teachers [ 9 , 10 , 11 , 12 , 13 , 14 ].

A study addressing cracks in problem-based learning suggested focusing on training new staff, maintaining briefing/debriefing sessions, reviewing materials and program based on feedback, monitoring program delivery, reviewing management, aligning assessment with PBL principles, ongoing curriculum maintenance, providing ongoing tutor training, and resolving conflicts to maintain healthy PBL delivery [ 3 ].

Studies conducted on Barriers to Implementing Problem-Based Learning (PBL) in Sub-Saharan Africa, including Ethiopia, are limited. In Ethiopia, only limited research on PBL was published and was mainly focused on the knowledge and attitude of academics and students toward PBL. Therefore, this study was aimed to explore specific barriers to the implementation of problem-based learning (PBL) at Debre Berhan University, School of Medicine, that could serve as a trigger for further nationwide studies.

Methods and materials

Study design, settings and participants.

A qualitative cross-sectional study was conducted at the Debre Berhan University medical school from February 1 to February 30, 2022. Debre Berhan University is located 130 km northeast of the capital Addis Ababa. The medical school consisted of 107 academic and 24 technical personnel during the study period. The school had a total of 117 year 1 and year 2 medical students during the study period.

Sample size and sample procedures

In the student selection process, we chose students with diverse academic backgrounds, ensuring representation from various degree programs (first degree in health and health related departments was a requirement to join medical school). Additionally, we considered the academic performance of the previous semester to include students from different academic performance categories.

Consequently, we selected 16 students from year 1 and year 2(PBL is given only for year 1 and 2 students). These students were then divided into two groups, with eight students in each group from each year. We conducted group discussions and continued data collection until we reached saturation of ideas. Saturation was deemed reached when ideas became repetitive and the group facilitator concluded that no new insights were likely to emerge.

For staff selection, our focus was on academic staff members with substantial teaching experience in problem-based learning (PBL) and demonstrated active involvement in such instructional methods. Based on these criteria, we interviewed a total of 15 academic staff using a semi-structured questionnaire. Finally, academic leaders, including the biomedical sciences coordinator and the medical school dean, were interviewed.

Data collection procedures

In the last week of January 2022, a pilot study was conducted to test the suitability and clarity of the interview guide. Constructive comments received from the pilot study participants were used to revise the interview guide. The data from the pilot study were not included in the results of the main study. Data collection for the main study was carried out by researchers from February 1, 2022, to February 30, 2022, using semi-structured interviews and key performance indicators (KPI).

By gathering data from these different sources, such as interviews and focused group discussions (FGD), a comprehensive understanding of the phenomenon and the achievement of the study objectives were ensured. This triangulation of data sources increased the credibility of the study findings. The data collected included information on sociodemographic, PBL cases, mode of delivery of PBL, and assessment of students.

The interview guide questions were initially prepared in English and then translated into Amharic language. An expert in both languages checked for consistency in the questions. Both the focus group discussion (FGD) and interviews were conducted and data was collected until saturation of ideas was reached, which occurred when ideas were repeatedly raised and the facilitator of the group (interviewer) believed that no new ideas would be raised, at which point the group discussion was stopped.

Data quality management and confidentiality

To ensure data quality, all study participants were informed about the relevance of the study and the confidentiality of the information. The author ensured that data collection methods aligned with research objectives and are appropriate for the study. Pretest data collection was undertaken so that the validity and appropriateness of the questions included was questioned. Triangulation, using multiple sources of data, was used to improve the credibility and reliability of the findings. Saturation was also employed, in which data collection continued until data saturation was reached to ensure a comprehensive exploration of the research questions. The information collected from the patients was not used for any purpose other than the intended purpose mentioned in this research.

Data analysis

Spradley’s four steps of data analysis [ 15 ], were utilized, including domain analysis, taxonomic analysis, component analysis, and theme analysis. In the first step, the data was examined to identify units of cultural knowledge that fell into larger categories based on their similarities or semantic relationships. This analysis was performed across the entire data set. The second step involved establishing a classification system for the identified domains, revealing the internal structure of each domain and the relationships among the categories within them. Moving on to the third step, the relationships between terms within each domain were identified and examined, as well as any differences among the terms or subcategories within a domain. Finally, in the fourth step, the researcher explored and uncovered the relationships among domains and themes throughout the entire data set. A theme map, consisting of a list of themes and subthemes, was developed and used to check the themes [ 16 ].

During this process, themes that did not generate meaningful data were discarded. The identified themes were revisited to identify similarities and differences in meaning. Furthermore, relevant literature from previous studies was reviewed to confirm the applicability of the identified themes and allow the researcher to draw the necessary inferences. As a result, four main themes and related subthemes were discovered, based on the characteristics and factors that influence the implementation barriers of Problem-Based Learning (PBL) within the School of Medicine.

Sociodemographic characteristics of study participants

This study involved a total of 16 medical students, aged between 24 and 27, with a male majority of 12 participants. In parallel, 15 academic staff members participated in this study, and the majority of them [ 11 ] were male with a range of age from 30 to 35. All academic staff held the academic rank of lecturer, and both the school Dean and the biomedical science coordinator carry the designation of assistant professor.

Theme 1: student-related barriers

Resistance of students towards pbl implementation.

There were instances where students showed resistance to participating in Problem-Based Learning (PBL) sessions. One of the tutors said: “ Some students did not perceive PBL as an effective teaching methodology; they need us to tell them everything in detail ”. The tutor continued: “ This resistance is often observed in students who had previously experienced a more traditional teacher-directed approach to education during their high school and undergraduate courses at the university ”. Students encountered difficulties transitioning from a passive to an active learning environment and expressed fear of being challenged by tutor questions.

Although many students expressed interest and are comfortable teaching using Problem-Based Learning (PBL) methodology, they acknowledge that it requires significant time for preparation and self-study. Students said ‘we are asked to read a large volume of information in a short period of time; there is only a one-day gap between the two sessions of PBL and it is very difficult to cover all objectives of the session; we need to read all the basic sciences included in the session, which is very difficult and tidies’. Unfortunately, some students attended PBL sessions without completing the necessary readings and preparations. Furthermore, there are students who believe that PBL sessions involve irrelevant discussions and consider them a waste of time.

Lack of consensus among students

In the context of Problem-Based Learning (PBL), students are required to collaborate within their teams. However, a common issue reported by many students is the absence of a shared understanding among team members. Some of the students reported that ‘some of us lack the willingness to work towards the same goals and some group members do not show responsibility and some team members considered PBL useless and did not prepare’. Students complained that these factors contribute to difficulties in effectively working together as a team.

Dominance of a few students in PBL sessions

One notable observation in problem-based learning (PBL) sessions is the tendency for a small group of students to dominate the discussions. One of the students said, ‘Some students are overactive and wanted to take control of the conversation during the session.’ They wanted to tell everyone they know, even those issues that are not related to the session. And some of the tutors have the tendency to follow them instead of controlling them and giving chances to other students”. Unfortunately, this dominance can hinder the participation of other students and limit their opportunities to contribute to the discussion.

High expectations of students towards tutors

Due to their unfamiliarity with this teaching methodology and the novelty of the curriculum, students do not fully understand their role as learners and the role of the tutor. Most of the tutors said: “ Some students expect much from us, they believe that we, the tutors, have the primary responsibility to discuss the whole issue during the discussion. They mistakenly believe that they are not required to invest significant effort and take ownership of their own learning process.' These students often anticipate that their tutor will bear the primary responsibility for their learning, placing a heavy reliance on their guidance and support.

Insufficient communication skills hinder participation

Some students have been observed to struggle with shyness or discomfort when speaking in front of a group. One of the group members said that ‘we have a discomfort speaking in front of our friends and tutors; we also have language barriers to discuss our readings’. These students found it challenging to express their thoughts and ideas confidently, leading to a reluctance to actively participate in discussions. In addition, language barriers pose another obstacle for some students. Those who are not fluent in the language of instruction encountered difficulties in articulating their ideas effectively.

Theme 2: barriers related to tutors

Lack of motivation in the implementation of pbl.

One of the significant barriers identified in the implementation of Problem-Based Learning (PBL) was the lack of motivation and unwillingness among tutors to deliver PBL sessions. Tutors have expressed three main reasons for their lack of motivation and resistance to participating in PBL.

First, the tutors have mentioned their dissatisfaction with their passive involvement during the sessions. ‘We feel that our time is wasted without making significant contributions to group discussions. This lack of active engagement diminishes our motivation to fully participate in the PBL process”.

Second, the tutors have highlighted the challenge of addressing multidisciplinary subjects within the PBL framework. They said that “despite the fact that the case requires knowledge from various disciplines, only one tutor, who is an expert in a single subject, is expected to lead the session. We find it tedious and tiresome to constantly read and prepare for subjects outside of our area of expertise, further reducing our motivation”.

Lastly, tutors have expressed a lack of incentives for their participation in PBL. ‘There is no special recognition or reward for our efforts in facilitating PBL sessions, which diminishes our motivation to actively participate’.

Work overload in PBL implementation

Another significant challenge that has been raised by both tutors and higher-level authorities, such as the department head and the school dean, is the issue of work overload. This concern stems from a shortage of staff available to serve as PBL tutors. The head of the biomedical department said that “ Currently, only a limited number of general practitioners and biomedical science instructors have received training to serve as a tutor and are responsible for delivering PBL sessions on a weekly basis’. This shortage of trained tutors created a heavy workload for staff, as they are required to facilitate multiple PBL groups simultaneously.

Lack of training and experience in PBL

Many tutors come from medical schools that follow conventional teaching and learning methodologies, where PBL is not commonly used. “There is no adequate PBL training for newly engaged staff; many of us are asked to facilitate PBL sessions without taking introductory training on how to lead PBL sessions. Without proper training, it is challenging to familiarize ourselves with the principles of PBL and develop the necessary skills and become effective facilitators.' Furthermore, most of the tutors have served less than a year in their role as PBL tutors in the school, further intensifying their lack of experience in this teaching methodology.

Clinical-focused tutors in PBL

Students complained that most tutors, who are primarily clinical staff, tend to prioritize the clinical aspects of case scenarios rather than guiding students to delve into the underlying basic science. Students have expressed their dissatisfaction, stating that “ we are often asked clinical questions such as how to diagnose and manage a given patient presented in the case scenario, rather than being encouraged to discuss the fundamental science behind it”. This mismatch between the tutors’ focus on clinical aspects and the students’ expectation to explore basic science concepts has led to frustration among the students.

Insufficient tutorial skills and evaluation-focused tutors

Some tutors exhibit inadequate tutorial skills, as they prioritize their own input and fail to create an inclusive learning environment that encourages student participation. Students complained that ‘Instead of facilitating discussions and fostering collaborative learning, some tutors tend to dominate the session with their own perspectives and start acting as a lecturer in the class room’. Furthermore, students have expressed frustration with tutors who focus primarily on evaluating their performance rather than supporting their learning journey.

Theme 3: PBL Case-related barriers

Ambiguous case scenarios.

The Problem Based Learning (PBL) cases listed in the curriculum are often unclear, causing confusion for both students and tutors. Tutors have expressed their concerns, stating that “ some of the cases lack clarity and do not provide a clear objective for discussion. In certain cases, PBL cases are exceptionally difficult to understand, lacking a clearly stated objective ‘.

Allocation of time in PBL cases

The allocation of time for each problem-based learning (PBL) case is a frequent issue that has been highlighted by both students and tutors. A common comment shared by most students was that “giving equal time for all cases is not fair.” They further explained that “ The current practice of allocating equal time for each PBL case is problematic. Not all cases require the same amount of time for discussion and exploration. Some cases have more extensive underlying concepts that require additional time for in-depth discussion. On the contrary, other cases may be relatively straightforward and require less time for discussion.

The timing of PBL delivery

One of the issues raised by students is the lack of a standard way to deliver problem-based learning cases. This includes the misalignment or poor arrangement of PBL cases with class lectures. The students said that “ We usually discuss cases in our PBL session before we learn the basic science lecture in the class; which is one of the reasons not to actively participate during the first session of the PBL.” They suggested that it would be better if PBL was given after taking some class room lectures on the system and professional competency development (PCD), so that they could easily understand the case scenarios easily.

Theme 4: assessment-related barriers

Subjectivity in assessment methods.

Despite the existence of an assessment tool prepared by the department, many tutors do not utilize it. Instead, they rely on their subjective judgment to evaluate students. Students said that “ most tutors do not use the assessment check list; they simply evaluate us based on their subjective judgment and that creates disappointment for students” .

On the contrary, the teachers have expressed their reservations about the assessment tool. Most tutors said that ‘the assessment tool is too complex and subjective to apply; it is tedious and time consuming to use it.’

Lack of ongoing evaluation

Students complained that ‘Many tutors evaluate us at the end of the module or occasionally during the course, rather than providing continuous assessment and feedback.’ This practice has led to dissatisfaction among students who expressed their disappointment as ‘it is unfair and does not accurately reflect our efforts and capabilities’. They added ‘someone smart on the last day can get a good result, which is unfair; we have to be evaluated on an ongoing basis with appropriate positive feedbacks given to each student so that we can improve our weak side’.

This study identified barriers to implementing PBL that can be classified into four main categories: student-related, tutor-related, case scenario-related, and assessment-related. Student-related barriers such as resistance for PBL implementation, work overload, lack of common understanding between students, PBL session dominated by few students, students over expectation from the tutor, and lack of good communication skills are the main student-related barriers identified in this research. Studies done in Saudi Arabia, Brazil, Ghana and Malaysia also showed similar factors influencing the implementation of PBL [ 7 , 10 , 17 , 18 ].

Some students may resist the implementation of PBL because it requires a different approach to learning compared to traditional didactic methods. They may be adapted to passive learning styles and find the transition challenging. In some cases, a small number of students may dominate PBL sessions, either due to their assertiveness or their level of preparedness. This can lead to other students feeling marginalized or disengaged from the learning process.

Addressing these student-related barriers requires a multifaceted approach, including providing clear guidance and support for students transitioning to PBL, fostering a collaborative learning environment, and offering resources and training to develop essential communication and problem-solving skills. Furthermore, promoting a culture of openness to new learning methods and addressing concerns about workload can help alleviate resistance to the implementation of PBL implementation among students [ 13 , 19 , 20 ].

The main barriers related to the tutor identified were lack of motivation, lack of experience and training, tutors with clinical orientation, and tutors focused primarily on evaluation. Similar findings were identified in studies conducted in Ethiopia, Azerbaijan, Indonesia, Pakistan and Korea [ 21 , 22 , 23 , 24 , 25 ]. This is likely due to the fact that many tutors graduated from traditional teacher-centered curricula and lack the experience and skills needed to effectively facilitate and evaluate problem-based learning (PBL). Therefore, it is essential that the tutor training be continuous and comprehensive, allowing the tutor to internalize and implement PBL methods effectively.

Case-scenario-related barriers were the other thematic area assessed in this research. In this regard, unclear case scenarios, not enough time allocated, and lack of standard way of case delivery system were the most important points mentioned by the study participants. The objectives and scope of some PBL sessions are not clear and the time given for each session is not proportional to the actual time needed to accomplish the session. Some case scenarios lack quality and do not stimulate critical thinking and self-directed learning. Learning objectives also lack integrity of different disciplines and do not promote collaborative learning. Studies in Saudi Arabia, Ghana, and Egypt also revealed similar findings [ 7 , 26 , 27 ].

Using problem-based learning (PBL) as a teaching methodology can be highly effective, especially when PBL cases are standardized and accompanied by clearly defined objectives and scopes. This approach not only ensures consistency, but also reduces the workload of students by eliminating confusion about which materials to study for their preparation. By providing structured PBL cases with clear learning objectives and delineated scopes, educators can streamline the learning process and improve the overall effectiveness of PBL sessions [ 20 ].

Another assessment-related barrier highlighted by the students in this study was the subjectivity of assessment methods. In addition, students expressed concerns about the use of one-time spot evaluations, which they perceived as problematic. Studies done in Ethiopia and Ghana also showed similar findings [ 7 , 28 ]. Although there is an assessment tool prepared by the department, it lacks objectivity and is exposed for biased assessment of students, and that has to be clarified and objective. Tutors should provide progressive evaluation and feedback that would allow students to determine whether they reached requirements, went off track from the objectives, and reflection on processes of learning [ 29 ].

Limitation of the study

The study was carried out in a single medical school, and therefore the findings may not accurately reflect the comprehensive national barriers associated with the implementation of problem-based learning and large-scale nationwide studies are recommended.

Lack of both tutor and student commitment, lack of standardized cases, absence of a recognition of staff input, gap in communication skills, work overload, lack of continuous training and at the time of evaluation of students were identified as the main barriers to the implementation of PBL. These findings imply that continuous tutor training in PBL case facilitation, assessment, and evaluation is crucial. Standardized PBL cases should be prepared ahead and stored in the PBL case bank to ensure a continuous supply of varied cases for effective PBL facilitation.

Data availability

The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Debre Berhan University

Focus Group Discussion

Key Performance Indicator

Problem-Based Learning

World Health Organization

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Aklile Semu designed the study, conducted data analysis, drafts the manuscript and supervised the work in all phases.Dr. Ermiyas Endewunet designed the study, conducted the data analysis, drafts the manuscript and supervised the work in all phases.Besufekad Mulugeta conducted the data analysis, drafts the manuscript and supervised the workErzik Muhammed conducted the data analysis, drafts the manuscript and supervised the workDr. Tilahun Deresse conducted the data analysis, drafts the manuscript and supervised the work in all phases.Enguday Demeke Gebeyaw supervise data collection, conducted the data analysis, drafts the manuscript.

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Tefera, A.S., Melaku, E.E., Urgie, B.M. et al. Barriers to implementing problem-based learning at the school of medicine of Debre Berhan University, Ethiopia. BMC Med Educ 24 , 501 (2024). https://doi.org/10.1186/s12909-024-05252-1

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• Problem-based learning
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Pragmatic nationwide master observational trial based on genomic alterations in advanced solid tumors: KOrean Precision Medicine Networking Group Study of MOlecular profiling guided therapy based on genomic alterations in advanced Solid tumors (KOSMOS)-II study protocol KCSG AL-22–09

• Sun Young Kim 1 ,
• Jee Hyun Kim 2 ,
• Tae-Yong Kim 3 ,
• Sook Ryun Park 1 ,
• Shinkyo Yoon 1 ,
• Soohyeon Lee 4 ,
• Se-Hoon Lee 5 ,
• Tae Min Kim 3 ,
• Sae-Won Han 3 ,
• Hye Ryun Kim 6 ,
• Hongseok Yun 7 ,
• Sejoon Lee 8 ,
• Jihun Kim 9 ,
• Yoon-La Choi 10 ,
• Kui Son Choi 11 ,
• Heejung Chae 12 ,
• Hyewon Ryu 13 ,
• Gyeong-Won Lee 14 ,
• Dae Young Zang 15 &
• Joong Bae Ahn 6  

BMC Cancer volume  24 , Article number:  574 ( 2024 ) Cite this article

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Metrics details

Next-generation sequencing (NGS) has been introduced to many Korean institutions to support molecular diagnostics in cancer since 2017, when it became eligible for reimbursement by the National Health Insurance Service. However, the uptake of molecularly guided treatment (MGT) based on NGS results has been limited because of stringent regulations regarding prescriptions outside of approved indications, a lack of clinical trial opportunities, and limited access to molecular tumor boards (MTB) at most institutions. The KOSMOS-II study was designed to demonstrate the feasibility and effectiveness of MGT, informed by MTBs, using a nationwide precision medicine platform.

The KOSMOS-II trial is a large-scale nationwide master observational study. It involves a framework for screening patients with metastatic solid tumors for actionable genetic alterations based on local NGS testing. It recommends MGT through a remote and centralized MTB meeting held biweekly. MGT can include one of the following options: Tier 1, the therapeutic use of investigational drugs targeting genetic alterations such as ALK, EGFR, ERBB2, BRAF, FH, ROS1, and RET , or those with high tumor mutational burden; Tier 2, comprising drugs with approved indications or those permitted for treatment outside of the indications approved by the Health Insurance Review and Assessment Service of Korea; Tier 3, involving clinical trials matching the genetic alterations recommended by the MTB. Given the anticipated proportion of patients receiving MGT in the range of 50% ± 3.25%, this study aims to enroll 1,000 patients. Patients must have progressed to one or more lines of therapy and undergone NGS before enrollment.

This pragmatic master protocol provides a mass-screening platform for rare genetic alterations and high-quality real-world data. Collateral clinical trials, translational studies, and clinico-genomic databases will contribute to generating evidence for drug repositioning and the development of new biomarkers.

Trial registration

NCT05525858.

Peer Review reports

The rapid development of molecularly targeted agents and immunotherapies, coupled with high-throughput tumor profiling using next-generation sequencing (NGS), is steering medical oncology towards “precision medicine.” Several precision medicine clinical trials in the United States and some European countries have adopted pragmatic platform trial designs [ 1 , 2 , 3 , 4 , 5 ]. Some studies have demonstrated that molecular profiling-guided therapy (MGT), determined by the genomic profile of a tumor and assessed by a molecular tumor board (MTB), may improve clinical outcomes in patients with refractory solid tumors [ 2 , 6 ].

However, challenges remain with the clinical implementation of MGTs [ 7 ]. Molecular profiling remains expensive and is very intricate in terms of the number of target genes, variant calling procedures, and sequencing techniques [ 8 ]. Meanwhile, the expertise in interpreting and matching MGTs often varies among oncologists, especially those who work at community hospitals. Regulatory approval for MGTs is limited to very narrow indications (e.g., trastuzumab is approved for HER2 -amplified breast or gastric cancer but not for HER2 -amplified biliary or salivary gland cancer), and it is difficult to prescribe MGTs outside of regulatory approval for patients with rare actionable genomic alterations. In Korea, where prescriptions outside the approved indications are strictly controlled, access to MGT is limited unless patients participate in clinical trials using MGTs. However, the opportunity to enroll in clinical trials is restricted in Korea, especially outside the Seoul Metropolitan area [ 9 ].

We have previously conducted a pragmatic precision medicine trial, the KOSMOS-I pilot study, designed as a nationwide, prospective, multicenter, multi-cohort study of MGT within local clinical practice. Local NGS reports from patients with refractory metastatic solid tumors were assessed by a central molecular tumor board (cMTB), which convened twice weekly on a virtual platform. MGT options were provided in the form of the Therapeutic Use of Investigational Drugs (TUID) program, approved for individual patients by the Ministry of Food and Drug Safety (MFDS). MGT was found to be feasible for 51.3% (99/193) of the patients enrolled over just one year, from February 2021 to February 2022. This finding underscores the significant need for MGT in Korea and demonstrates the feasibility of MGT supported by nationwide cMTB [ 10 ].

Based on these results, we expanded the KOSMOS-I platform to enroll a larger number of patients. We designed a master observational trial (MOT), KOSMOS-II, which offers more MGT options, including TUID and investigator-initiated clinical trials (IITs), as part of the entire MOT framework. In this context, we describe the rationale and design of the KOSMOS-II trial, the current progress of this project, and discuss the operational issues and perspectives concerning this pragmatic platform.

Methods/design

Study design.

The KOSMOS-II trial comprises a framework for screening patients with actionable targets, operating a cMTB that recommends and provides MGT, and developing a clinico-genomic database (CGDB). MGT options include TUID with targeted and/or immunotherapies (Tier 1); local practice involving therapy within or outside the approved indications (Tier 2); or participation in clinical trials (Tier 3) (Fig.  1 ).

Study Scheme for KOSMOS-II trial. Abbreviations: NGS, next-generation sequencing; eCRF, electronic case report form; MTB, molecular tumor board; KSMO, Korean Society of Medical Oncology; KCSG, Korean Cancer Study Group; IP, investigational products; MGT, molecular profile guided therapy; IIT, investigator initiated clinical trials; Pt, patient

Study objectives

The primary objective of this study is to evaluate the feasibility of MGT in terms of the proportion of participants who received the treatment (MGT rate). The receipt of MGT is defined as receiving at least one dose of MGT targeting the genetic alterations (GAs) detected by NGS, regardless of the tier assigned by the cMTB. The second primary objective is to evaluate the effectiveness of MGT in terms of clinical benefit rate (CBR: the percentage of patients with complete response, partial response, or stable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ 11 ] beyond 16 ± 2 weeks of treatment) in Tier 1.

The secondary objectives include the following:

To evaluate the effectiveness of MGT in terms of the objective response rate, progression-free survival, treatment duration, and 1-year overall survival in Tier 1 and Tier 3A (investigator-initiated trials by KOSMOS-II study team), where the clinical outcomes of MGT are being captured.

To evaluate the safety of MGT according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

To assess the operational feasibility of delivering MGT.

To correlate the molecular profile with the clinical outcomes of MGT.

In this study, the explorative objectives are divided into translational and clinical objectives. The translational objectives are presented in the following section. The clinical explorative objective is to evaluate the extension of the MGT beyond the KOSMOS-I. In the KOSMOS-I trial, MGT was provided for up to 12 months. Therefore, the KOSMOS-II trial will enroll the patients after the completion of study treatment of KOSMOS-I if they do not experience disease progression to provide extended MGT. The clinical and molecular characteristics of the patients (prior KOSMOS-I participants) will be described separately from the whole study population.

Eligibility criteria

Patients with locally advanced or metastatic solid tumors are eligible for the study based on the following criteria: (1) progression on standard treatments or exhaustion of available treatment options; (2) patients have an available NGS report for the tumors, ideally obtained within the last 3 years, and provided by laboratories accredited by MFDS or regulatory bodies compatible with MFDS, such as Clinical Laboratory Improvement Amendments; (3) a life expectancy of at least 12 weeks; (4) observable adequate recovery from the most recent systemic or local treatment.

Study treatment

Table 1 presents the options available for Tier 1. These options are provided through TUID, which is available only for drugs that have already been approved for certain indications by MFDS, and it does not include investigational products without any approved indications. The KOSMOS-II centralized and standardized the TUID approval process for study participants. The protocol specifies the actionable GAs that match each drug on the Tier 1 list; however, the cMTB panel can recommend Tier 1 options if there is evidence that GAs other than the pre-specified ones can predict the benefit from the drug.

Tier 2 options include treatment according to local practice, such as chemotherapy for approved indications, if any, treatment outside approved indications that has been allowed by the Health Insurance Review and Assessment Service (HIRA), or best supportive care.

Tier 3 options, which involve participation in clinical trials, are always prioritized over Tier 1 or Tier 2 options, provided they are available. Clinical trials that assess MGT and are accessible in Korea are recommended. In particular, the opportunity to participate in IITs, supported by the KOSMOS-industry consortium (Table  2 ), is recommended if the patient is involved in the KOSMOS-II trial and the cMTB panel determines that the GAs from the patient’s tumor match the eligibility criteria of the IITs. These IITs, referred to as Tier 3A options, are designed in alignment with the master protocol of the KOSMOS-II trial to expedite the screening procedure within the KOSMOS-II platform and offer additional MGT options for KOSMOS-II participants while allowing them to explore the possibility of repurposing existing drugs.

Study process

After a participant signs an informed consent, their clinical information is entered into the electronic case report form, which automatically sends the information towards the virtual cMTB platform, NAVIFY®. The participants’ NGS report is separately uploaded to NAVIFY®. Seven cMTB panels are organized, each comprised of three to four medical oncologists and at least one or more pathologists or bioinformaticians. The virtual cMTB meetings are held twice a week. To ensure the participants’ personal information protection, the clinical information on NAVIFY® is pseudo-anonymized, and all members of the cMTB panels sign confidentiality agreements.

Overall, cMTB provides the following information after discussing each case:

Actionable genomic alteration from the subject’s NGS report

Preferred recommendations: (Tier 1, Tier 2, or Tier 3) (Fig.  1 )

Level of evidence per recommendation.

The level of evidence is assigned according to the Korean Precision Medicine Networking Group scale of clinical actionability of molecular targets (K-CAT) [ 12 ]; supporting references regarding the assigned K-CAT levels should also be provided. The cMTB can suggest a maximum of three treatment options in a hierarchy, and the investigator who submits the case can choose among the provided options.

The cMTB process is illustrated in Fig.  2 . The NGS report is reviewed and commented on by the panel pathologist and/or bioinformatician prior to the meeting. If a patient exhibit only one actionable GA that matches one of the treatment options of Tier 1, the case can be assigned to Tier 1 treatment through an expedited review by the panel chair (a medical oncologist), pathologist, and/or bioinformatician, without being fully reviewed by all cMTB members on an online forum. If a case is not recommended for expedited review, the medical oncologists on the panel search for clinical trials available in Korea that are relevant to the submitted case. This process involves checking the MFDS website ( https://nedrug.mfds.go.kr/index ), Korea Disease Control and Prevention Agency Clinical Research Information Service ( https://cris.nih.go.kr/cris/index/index.do ), and the Korean Cancer Study Group (KCSG) website ( https://www.kcsg.org ). Treatment options are determined after a discussion on the online forum regarding the interpretation of GAs and the available options obtained through the search.

Central molecular tumor board workflow in the KOSMOS-II trial. Abbreviations: NGS, next-generation sequencing; M.P, molecular pathologists; B.I, bioinformaticians; GA, genetic alteration; Pt, patient

The status of various clinical trials of MGT in multiple institutions is monitored and curated by the KOSMOS-II study team and regularly provided to the cMTB panel members. Online forums and educational workshops for cMTB are organized and supported by the Korean Society of Medical Oncology.

Study assessments

Pretreatment evaluations require clinically appropriate radiographic studies to assess target or nontarget lesions for each participant, according to RECIST v1.1 criteria. For those who participate in Tier 1, tumor assessments are performed every 8 ± 2 weeks, according to RECIST v1.1 or iRECIST (for those who were treated with atezolizumab). For those who participate in Tier 3A trials (Table  2 ), tumor assessment is performed according to the protocol of each study, and the intervals between assessments range from 6 to 8 weeks.

Tier 1 serious adverse events are collected according to CTCAE v5.0. In Tier 3A studies, adverse events are identified and assessed according to each protocol.

Translational projects and the master protocol

Several translational projects utilizing the KOSMOS-II trial are ongoing. The translational explorative objectives are as follows:

To correlate the response to immune checkpoint inhibitors with tumor mutational burden confirmed by local NGS testing.

To correlate the response to immune checkpoint inhibitors with the Lunit SCOPE IO, an artificial intelligence-powered spatial tumor-infiltrating lymphocyte analysis of digitized data from qualified scanned images of hematoxylin and eosin-stained slides. This analysis demonstrates its predictive role in various types of tumors, including non-small cell lung cancer [ 13 ].

To illustrate the genomic landscape of Korean patients with solid tumors through whole-genome sequencing (WGS) of participants who provided recently obtained tumor tissue (within 3 months from enrollment) and to explore the possibility of using WGS to identify the appropriate MGT.

Establishment of a clinico-genomic database

A specific collateral project of this study is the establishment of a nationwide CGDB in collaboration with the National Cancer Center of Korea (NCCK), designated the National Cancer Data Center (NCDC). The clinical characteristics of the participants, their genomic profiles, and outcomes of the MGT (Tier 1 and Tier 3A) are stored as anonymized codes and curated in the CGDB for further research and development. The resident registration numbers of the study participants are collected and transferred to the NCDC, where they are linked to the data by the Korean Statistical Information Service to update the survival status of the participants after the study ends. Efforts, such as collecting the metadata of each local NGS panel and transforming heterogeneous genomic variant call format (VCF) files into a standardized format, are ongoing to build the CGDB (Fig.  3 ).

Representation of the flow of integration and distribution of clinico-genomic data in the KOSMOS-II trial. Abbreviations: eCRF, electronic case report form; RRN, resident registration number; VCF, variant call format; KOSIS, Korean Statistical Information Service; NGS, next-generation sequencing; KCSG, Korean Cancer Study Group

KOSMOS-II investigators and companies participating in the KOSMOS Industry Consortium will have access to the CGDB, which will be transferred to the data center of the KCSG, the sponsor of this study. The KCSG has a partnership agreement with the NCCK to ensure and promote broad data sharing among academic societies, governmental organizations, and biopharmaceutical companies. The CGDB housed in the NCDC will be made available to the public 3 years after the completion of this study and distributed according to the pre-specified governance rules for the data.

Statistical considerations

Given that MGT was available for 51.3% (99/193) of patients in the KOSMOS-I trial [ 14 ], it is expected that the MGT rate in this study will be approximately 50%. To estimate the proportion of patients with a 95% confidence interval of 0.065, a total of 950 patients need to be included. Considering a 5% dropout rate, the plan is to enroll 1,000 patients in this study.

Considering the CBRs or disease control rates in previous genomically guided basket trials have ranged from 20 to 50% [ 4 , 15 , 16 ], the expected CBR of Tier 1 patients is 30%. Assuming the null hypothesis that the CBR is 20% or less, as might be expected from studies on investigational products reported in the early 2000s [ 17 ], 221 patients are needed to demonstrate that the true CBR is 30%, with a type I error of 5% (2-sided) and 90% power. Considering a 20% dropout rate, we need to enroll 265 patients in Tier 1. In addition, we will enroll approximately 35 exceptional responders from KOSMOS-I trial, resulting in a total of 300 patients being enrolled in Tier 1 for this study. The scope of data collection according to the endpoints in each tier is presented in Table  3 .

Current status

This study enrolled its first participant in September 2022 and 418 patients (42% of the projected number) as of October 2023. A total of 31 institutions across Korea participated in this trial, with 29 of the 31 institutions having started to enroll patients. The virtual cMTB held its 110th meeting in October 2023. The expected duration of this study is 3 years, including 2 years of enrollment and 1 year of follow-up.

This study is a type of MOT, a prospective observational trial that enrolls patients based on a precise molecular biomarker testing algorithm and incorporates interventional trials or real-world data (RWD). MOT is a new class of master clinical protocols proposed to bridge the gap between interventional trials and retrospective RWD in data collection for precision medicine [ 18 ].

MOT, such as the KOSMOS-II trial, can provide a common screening platform for various collateral studies. Identifying rare actionable GAs is challenging without comprehensive molecular testing in a large number of patients. The opportunity to offer patients innovative treatment options hinges on the seamless integration of the interpretation of molecular test results and drug-access programs, including clinical trials. The KOSMOS-II trial employed various NGS panels certified by healthcare authorities, such as MFDS, to efficiently screen participants and reduce the time and cost associated with testing and logistics.

In Korea, NGS for clinical diagnosis can only be performed by clinical laboratories certified according to the laboratory guidelines of MFDS. Most laboratories perform comprehensive genomic profiling, testing hundreds of genes, and follow the good laboratory standards of the Korean Society of Pathologists [ 8 ]. However, the heterogeneity of the panels in terms of sequencing methods, covered gene regions, and variant calling pipelines poses challenges in constructing a molecular matrix for MOT. To address these issues, the KOSMOS-II study team collects metadata for each submitted NGS panel, including the list and number of targeted genes, sequencer type, reference sequence, target capture kit, and variant-calling software. Even in the absence of a unified testing platform, this standardized curation of detected variants for each participant helps to provide reliable information about the actionability of the GAs. The Targeted Agent and Profiling Utilization Registry (TAPUR™) trial has already demonstrated that heterogeneous molecular testing methods can serve as platforms for precision medicine trials [ 3 ]. Our trial is anticipated to provide evidence supporting an efficient and pragmatic framework for nationwide screening in the realm of drug development and repositioning.

RWD is increasingly used to assess the impact of drugs in daily practice and to support the drug approval process, helping to address the limitations of clinical trial data. It can provide information about underserved populations or individuals with underlying diseases or organ dysfunction who are ineligible for clinical trials [ 19 ]. However, the accuracy of data, such as molecular annotations or clinical events (disease progression, recurrence, or adverse events from treatments), for cancer patients is often questioned in RWD because of the heterogeneity of testing methods and the result reporting, as well as non-standardized reports regarding efficacy and safety outcomes [ 18 ]. MOT can mitigate the disadvantages of RWD by prospectively collecting clinical data using a common case report form, while treatment and evaluation schedules are more flexible compared with those of traditional clinical trials [ 20 ]. In the KOSMOS-II trial, clinicopathologic information for all registered patients is being collected prospectively, and the response to MGT in Tier 1 and Tier 3A patients is being recorded according to the RECIST 1.1 criteria (also iRECIST for patients receiving immune checkpoint inhibitors).

Many precision medicine trials have shown that one or more potentially actionable GAs can be identified in approximately 30%–50% of patients, with approximately 10–20% of them being eligible for MGT [ 1 , 2 , 4 , 6 , 16 , 21 ]. Some studies have demonstrated improved clinical outcomes with MGT compared with conventional therapy [ 2 , 6 ]. The proportion of patients eligible for MGT can vary depending on the type of molecular profiling platform, the availability of MGT options, and the investigators’ treatment intentions. As demonstrated by our previous study, KOSMOS-I, we achieved a matching rate of 51.3% by implementing the cMTB combined with the TUID program, along with efficient communication for clinical trial enrollment among cMTB members and investigators. This rationale led us to hypothesize that the MGT rate is 50% in KOSMOS-II. The expected CBR in Tier 1 is 30%, which is a significant improvement for heavily treated and refractory populations. However, achieving desired efficacy levels may be challenging because in many cases, the genomic profiles for MGT are derived from the sequencing results of tumor samples obtained significantly earlier than the treatment, which may not accurately reflect the genomic profile at the time of MGT implementation. To address these concerns, we encourage investigators to submit NGS results from the most recently obtained tumor samples and to enroll patients in a WGS translational project using fresh tissue samples.

To the best of our knowledge, this is the first multicenter, nationwide precision medicine study that utilizes cMTB for all participants. While discussions on MTBs may positively affect treatment decisions [ 22 ], increase the likelihood of enrollment in clinical trials, and potentially improve clinical outcomes [ 23 ], the associated turnaround time and cost might prevent the adoption of MTB in clinical practice [ 24 ]. Additionally, MTBs have not been actively employed in many Korean institutions because of disparities in human resources, infrastructure for NGS interpretation, and clinical trial access [ 9 ]. The KOSMOS-II trial involves 31 institutions from all over South Korea, and 12 of them are located outside the Seoul metropolitan area. To facilitate cMTB in this large-scale study, we use a video-conferencing platform and clinicopathologic information curating software, NAVIFY®. Our study aims to measure the operational feasibility of a nationwide cMTB by assessing the turnaround time from the site’s request to the cMTB’s decision, and by examining the agreement rate between the cMTB’s recommendation and the actual treatment administered to patients. Furthermore, we aim to gauge the consensus among different panels on similar cases, particularly in assigning a level of clinical actionability to individual cases.

Through the KOSMOS-II trial, we also aim to develop a CGDB that includes participants’ clinical characteristics and genomic profiles by processing VCF files from various platforms, which will be linked to reliable survival data provided by national mortality statistics. Several collaborative efforts have been made to develop real-world CGDBs to assess the effects of genomic profiling and MGT on patient care [ 25 , 26 ]. The CGDB for the KOSMOS-II study will contribute significantly to precision medicine by providing high-quality clinical data and accurate genomic information.

In conclusion, the KOSMOS-II trial is designed to test the hypothesis that cMTB-based MGT approach is both feasible and effective for treating refractory solid tumors on a nationwide scale. This MOT, incorporating RWD and IITs, is expected to provide an efficient platform for identifying new indications or biomarkers for existing drugs as well as investigational agents. In addition, the CGDB developed through the KOSMOS-II trial may contribute to collaborative efforts aimed at data-informed clinical decision-making.

Availability of data and materials

No datasets were generated or analysed during the current study.

Abbreviations

Next-Generation Sequencing

Molecularly Guided Treatment

Molecular Tumor Board

Central Molecular Tumor Board

Therapeutic Use of Investigational Drugs

The Ministry of Food and Drug Safety

• Master observational trial

Investigator-initiated trial

Clinico-Genomic Database

Genetic Alterations

Clinical Benefit Rate

Response Evaluation Criteria in Solid Tumors

Common Terminology Criteria for Adverse Events

The Health Insurance Review and Assessment Service

Korean Precision Medicine Networking Group scale of clinical actionability of molecular target

Korean Cancer Study Group

Whole genome sequencing

National Cancer Center of Korea

National Cancer Data Center

Variant Call Format

Real-World Data

Targeted Agent and Profiling Utilization Registry trial

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Acknowledgements

We gratefully acknowledge the support for this project and the manuscript by the staff of Korean Cancer Study Group (Hye-Yeon Jeon, Minju Lee, Sungsoo Kim, and Jinyeong Baek) and Korean Society of Medical Oncology (MiMinkyung Song). We also thank to our research coordinators, (Mijung Kwak, Na An) for their devoted contribution on this project.

The National R&D Program for Cancer Control, Ministry of Health and Welfare, Republic of Korea (Grant # HA22C0052) awarded support for this study through scientific peer review as part of the grant application for the Investigator-Initiated Multi-Center Clinical Trial Support Program.

KOSMOS—Industry Consortium including Roche (Basel, Switzerland) and Lunit (Seoul, Republic of Korea) also provided funding for this study.

The funders of the study have no role in the study design, data collection, data analysis, or data interpretation. The funding bodies will be informed of any planned publications.

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Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

Sun Young Kim, Sook Ryun Park & Shinkyo Yoon

Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea

Jee Hyun Kim

Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea

Tae-Yong Kim, Tae Min Kim & Sae-Won Han

Department of Internal Medicine, Korea University College of Medicine, Korea University Anam Hospital, Seoul, South Korea

Soohyeon Lee

Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

Se-Hoon Lee

Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Yonsei Cancer Center, Seoul, South Korea

Hye Ryun Kim & Joong Bae Ahn

Center for Genomic Medicine, Seoul National University Hospital, Seoul, South Korea

Hongseok Yun

Center for Precision Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea

Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

Yoon-La Choi

Department of Cancer Control and Population Health, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, South Korea

Kui Son Choi

Department of Internal Medicine, National Cancer Center, Goyang, South Korea

Heejung Chae

Division of Hematology and Oncology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, South Korea

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Contributions

All authors (SYK, JHK, TK, SRP, SY, SL, SL, TMK, SH, HRK, HY, SL, JK, YC, KSC, HC, HR, GL, DYZ, and JBA) reviewed and approved the final version of the manuscript. SYK, JK, TK, HY, SL (Sejoon Lee), KSC, HC, HR, and GL conceptualized this study. SRP, SY, SL (Soohyeon Lee), SL (Se-Hoon Lee), TMK, SH, HRK, HY, SL (Sejoon Lee), JK, and YC participated in research activity planning and execution. DYZ and JBA supervised the study. Funding was obtained by JHK. SYK contributed to the writing of the original draft, and all authors contributed to revising the manuscript.

Corresponding author

Correspondence to Jee Hyun Kim .

Ethics declarations

Ethics approval and consent to participate.

This study was approved by the Institutional Review Board and Protocol Review Committee of the Korean Cancer Study Group (protocol number AL22-09) and by the review boards of all 31 institutions. Informed consent will be obtained from all patients and/or their legal guardian(s) in compliance with the Declaration of Helsinki.

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Not applicable.

Competing interests

SYK receives research funding from Roche/Genentech. JHK receives research funding from Eisai, Ono Pharmaceutical, and Roche. SRP has receives research funding from ImmuneOncia Therapeutics, ONO Pharma Korea, and Incyte. SL (Soohyeon Lee) has stock and other ownership interests of Celgene/Bristol-Myers Squibb and Pfizer and receives research funding from Jeil Pharmaceutical Co. SL (Se-Hoon Lee) receives research funding from AstraZeneca, Lunit, and Merck. TMK has consulting or advisory roles outside this work, related to Amgen, AstraZeneca/MedImmune, Boryung, Daiichi-Sankyo, HK inno.N, IMBDx. Inc., Janssen, Novartis, Regeneron, Roche/Genentech, Samsung Bioepis, Takeda, and Yuhan. HRK received honoraria from AstraZeneca, Bristol Myers Squibb, Genentech/Roche, stock ownership in Bridgebio Therapeutics; served as a consultation or advisory role for Bayer, AstraZeneca, Bristol Myers Squibb, Takeda, and Yuhan; and received research funding from the Yonsei Lee Youn Jae Fellowship outside of the current work. YC is employed and has stock and other ownership interests with Abion. JBA receives research funding from Sanofi. The remaining authors declare no conflict of interest that are relevant to the content of this article.

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Kim, S.Y., Kim, J.H., Kim, TY. et al. Pragmatic nationwide master observational trial based on genomic alterations in advanced solid tumors: KOrean Precision Medicine Networking Group Study of MOlecular profiling guided therapy based on genomic alterations in advanced Solid tumors (KOSMOS)-II study protocol KCSG AL-22–09. BMC Cancer 24 , 574 (2024). https://doi.org/10.1186/s12885-024-12338-y

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Received : 31 December 2023

Accepted : 03 May 2024

Published : 09 May 2024

DOI : https://doi.org/10.1186/s12885-024-12338-y

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