project plan in clinical research

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Clinical research project management: back to basics.

Clinical trials require care and precision regarding planning, coordination, and collaboration. The stakes are high, with participants’ health and well-being and significant investments of both time and money on the line. That’s why clinical research project managers are necessary – to ensure coordinated and collaborative efforts between numerous departments, teams, and vendors that adhere to the study protocol as well as regulatory and ethical standards. In this article, we will take an in-depth look at the basics of clinical research project management.

What is project management in clinical research?

Clinical trials involve several complex, dynamic parts with different boundaries/areas of responsibility, and personnel with specific skill sets and qualifications. As a consequence, successful clinical trials require organizers who are adept at project management.

Clinical trials can be thought of as large-scale, complex projects with multiple milestones and parallel workstreams, including:

• Study and protocol design
• Study startup
• Site activation
• Recruitment
• Documentation (promotional material, informed consent forms, case report forms, protocol documents, surveys, etc.)
• IRB and IEC approval
• Site management
• Investigational product distribution and management of study materials
• Laboratories (analyses, lab tests, imaging, etc.)
• Reporting and regulatory affairs

Why is project management in clinical research important?

Clinical research involves multiple stakeholders. Project management can essentially be thought of as monitoring progress and keeping everyone involved on the same page. Project management is critical for the success of a clinical trial; it helps the different teams stay on schedule, adhere to protocol, and communicate amongst one another, as well as meet the trial objectives/targets, maintain quality standards, stay within budget, and follow regulatory requirements.

The following are three major reasons why project management in clinical research is important:

Timeline management

Project management ensures the delivery of clinical trial objectives and sub-objectives within the allocated time and budget. This is important because nearly 85% of all clinical trials experience delays. [1] Project management techniques can allow investigators to plan ahead if it looks like a deadline is not going to be met, so they can reallocate resources and priorities to accelerate the process, or otherwise notify teams responsible for tasks that would be affected by the resultant delay and adjust the timelines.

Streamline and facilitate communications

It is important for the various stakeholders involved in a clinical trial to be on the same page. Keeping all of these actors updated and facilitating communication amongst them is another task of the project management team. Lack of communication in clinical trials can have negative consequences on the quality of research. [2] An efficient project manager or management team can streamline communication and collaboration between multiple teams and departments, further increasing the transparency of the individual but interdependent operations.

Quality control (QC)

Quality control is another important aspect of clinical research project management. Quality standards are often stringent, but this is designed to protect the safety of participants and the general population. Clinical trials that fail to adhere to or meet quality standards will not be considered to have provided sufficient evidence on the effectiveness and/or safety of an investigational drug. Researchers and investigators tend to be under a lot of pressure as trials are often on tight budgets and timelines, but it is important that quality not be sacrificed in order to meet other objectives.

Project management helps sponsors/investigators manage all objectives and sub-tasks in a clinical trial while still prioritizing adherence to quality and regulatory standards. Part of the task of the project management team may even be to define internal quality standards for specific tasks, objectives, and/or teams.

What does a clinical research project manager do?

A clinical research project manager coordinates with other departments, teams, and personnel involved in the clinical trial to ensure the organized completion of clearly defined tasks. They also manage external vendors such as central laboratories or technology providers. Project managers will monitor the progress of all tasks and objectives to keep the study on track according to its protocol, including timeline and budget, and also communicate with stakeholders such as the sponsor to keep them up to date.

What is the clinical research project manager responsible for?

The responsibilities of a clinical research project manager depend on the specifics of the trial and its complexity, but they generally include the following:

• Planning : This includes general planning of the trial, including the internal organization between departments/teams, how tasks should be executed in order to comply with regulations, how many and which sites to involve, whether external tools/solutions need to be contracted, etc.
• Budgeting : Making sure that the study’s resources are allocated appropriately to the different teams/tasks, within the overall study budget, also providing room for unexpected costs or delays.
• Vendor identification/selection : Negotiation with vendors, technology providers, and suppliers.
• Scheduling : Scheduling the objectives/sub-tasks of the clinical trial and monitoring activities to make sure they are completed on time.
• Liaising : Acting as a central point of contact for members of the project team and sponsors.
• Task delegation : Assigning tasks to team members and updating them about their responsibilities, as well as deadlines and expectations.

What are the key topics included in a clinical research project plan?

The project manager may organize all of the above-mentioned tasks and responsibilities into a document or repository referred to as a clinical research project plan. This plan would formally outline standard protocols for aspects of the clinical research project management, such as:

• Timeline : The timeline should clearly outline specific tasks for each team/department, including their expected initiation and completion dates, and the project manager will ensure tasks and teams are on track. Clinical trials often get delayed, so it is useful to have protocols in place regarding how to deal with potential delays. [3]
• Budget : Often related to unexpected delays, it is not uncommon for projects to end up over budget. The project plan should clearly define budgets, both for teams and for individual tasks, and should outline how deviations from budgets should be dealt with.
• Stakeholder management : The project management plan should outline the content and dates of formal reports for keeping stakeholders updated about the trial’s progress.
• Documentation : The project plan should outline how documentation should be collected, organized, stored, and verified in order to ensure compliance with laws as well as ethical and clinical standards as established by the WHO and ICH guidelines for Clinical Good Practice.
• Site management : Although site monitoring is usually a separate responsibility in clinical trials, the project plan may include instructions and guidelines for individual study sites regarding adherence to protocol, tasks, and timelines. In addition, sites should have clear guidelines on who to contact in the case of any problems, questions, or adverse events that may arise during the trial.
• Data management : The project plan should specify protocol for the collection, secure storage, management, validation, and cleaning of subject information and trial data, in accordance with quality standards and applicable regulations. Proper data management ties in closely with quality assurance, and sound results require healthy data.

Tips for successful clinical research project planning and management

Here are 4 specific tips and ideas for maximizing the efficacy of project management functions in clinical research.

1. Plan with flexibility

Delays can be hard to avoid, especially in the recruitment stage, and they are costly to sponsors. Nonetheless, proper consideration of these potential delays in the timeline (i.e., allowing for some degree of flexibility) can make the difference between the delays simply setting the trial back a few weeks, or ending in the entire trial being canceled.

While delays aren’t ideal, proper planning can allow the sponsors to absorb these delays without them leading to completely missed deadlines and/or cancellation of the trial; in the end, cancellation likely represents a much more significant waste of resources than delays. The same logic can be applied to flexibility in budgeting, as delays may imply additional costs; if these are less unexpected, they can be better absorbed within the trial budget without setting it entirely off track.

2. Identify possible risks and establish mitigation strategies

Perform a thorough analysis of the protocol and utilize specialist knowledge in the fields of medicine and clinical research management to identify and create a list of risks that could arise throughout the clinical trial. Planning ahead of time will allow sponsors to respond rapidly to these risk factors and mitigate them, without having to perform lengthy analyses and coming up with mitigation strategies when it may be too late.

Some potential risks to consider include recruitment delays or low accrual, adverse events, patient dropouts, protocol breaches, problems with study drug supply or distribution, technical failures (of software systems, medical equipment, etc.), and data integrity issues, to name a few. Start with the risks that pose the greatest threat to the integrity of the study, i.e., those which would result in it being canceled, stopped, or rendering the results unusable.

3. Use project management tools

Constantly reviewing all aspects of the clinical trial is a daunting task, so the use of specialized and customizable software solutions can be helpful. There are many such solutions available, from general project management tools to dedicated clinical trial management systems ( CTMS ). These tools can be of significant help in managing, organizing, and overviewing all of the aspects of project management discussed previously, acting as a sort of central dashboard as well as a “safeguard” for the project management plan and tasks.

4. Leverage data automation tools and functions

Similarly to the previous point, data management is another aspect of clinical trials (and clinical trial project management) that can benefit greatly from the assistance of technological tools. Lots of data management functions, including organization, cleanup, and validation, can be streamlined or even completely automated through data processing tools, which are sometimes integrated directly into CTMS or other clinical trial monitoring solutions. The benefits of healthy data include enhanced regulatory compliance and faster progression to data analysis and results once the study data has been collected. Data can also be improved at the source through the use of electronic reporting/collection/recording methods such as:

• Electronic patient-reported outcomes ( ePRO )
• Electronic trial master files ( eTMF )
• Electronic clinical outcome assessments ( eCOA )
• Electronic case report forms ( eCRF )

Conclusions

Clinical research project management is a vital function for keeping the numerous separate yet highly interconnected parts involved in a clinical trial operating in coordination and on track with protocol, budget, timelines, and regulations. There are numerous strategies and tools that can facilitate clinical trial project management tasks and help improve clinical trial quality and speed while still ensuring patient safety and regulatory compliance.

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Using project management principles to improve research projects

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After reading this article, you should be able to:

• Understand the principles of project management and how they can be applied to clinical trials;
• Identify some of the tools that can be used for research project management;
• Understand the role of the pharmacist in these processes .

Introduction

Research is an integral component of any modern healthcare service that incorporates evidence-based practice, where clinical decisions are made based on available research to ensure balanced and appropriate clinical guidance ​[1]​ . The current high standards of medical care are partly attributable to the clinical studies that have been conducted under the guidance and funding of regulatory bodies, such as the National Institute for Health and Care Research (NIHR) and the UK Medical Research Council. In addition to testing new drugs and devices, clinical trials provide a scientific basis for advising and treating patients, contributing immensely to safe and effective clinical practice.

Pharmacists play a vital role in the clinical trial process. They are often responsible for dispensing medications and ensuring that the study protocol is followed correctly. Additionally, pharmacists can provide valuable input in the design of clinical trials, particularly in areas related to medication dosing and drug interactions ​[2]​ . They can also assist with data collection and analysis, which is essential for evaluating the safety and efficacy of new medications.

Applying project management principles to clinical research has the potential to improve efficiency across the research process. This article will outline the five basic phases of project management and show how they can be beneficial to research projects. It will also highlight the role of the pharmacist in clinical research and show how common obstacles to project management approaches can be overcome.

Managing clinical trials

A successful clinical trial requires organisation and the effective execution of activities and tasks, within given timelines and in a step-wise manner, and must be managed meticulously to avoid unnecessary delays and problems. It can be a time-consuming, difficult and challenging task that must be fulfilled with a finite budget, and therefore requires careful planning and organisation from the onset. An analysis of 114 multi-centre clinical trials showed that 45% of trials failed to reach 80% of the pre-specified sample size required to obtain significant data, and around a third were unable to recruit study participants within the time specified and had to extend, costing more time and resources ​[3]​ .

Box 1: Clinical trial phases

Clinical trials are divided into four phases, each with its own purpose and design.

Phase 1: Trials are the first step in testing a new drug or treatment in humans. They are conducted to evaluate the safety of the drug and determine the appropriate dosage. Typically, phase 1 trials involve a small group of healthy volunteers, who are closely monitored for adverse effects. Phase 1 trials can last several months, and the results are used to inform the design of subsequent trials.

Phase 2 : Trials are conducted to evaluate the safety and efficacy of the drug or treatment in a larger group of patients. These trials can last several years and involve hundreds of participants. Phase 2 trials also determine the optimal dosage and any potential side effects.

Phase 3 : These trials are the largest and most expensive phase of clinical trials. They are designed to confirm the safety and efficacy of the drug or treatment in a large, diverse population. Phase 3 trials can involve thousands of participants and can last several years. The results of phase 3 trials are used to support an application for approval by regulatory authorities, such as the US Food and Drug Administration.

Phase 4 : Trials are conducted after a drug or treatment has been approved by regulatory authorities and is on the market. These trials are designed to monitor the long-term safety and efficacy of the drug or treatment in a larger, more diverse population. Phase 4 trials can also be used to explore new uses for the drug or treatment, or to compare it to other treatments ​[4]​ .

Applying project management principles to clinical trials

We propose that clinical trials can be conducted more efficiently using project management principles. A project is any temporary endeavour that has a clear beginning and end, clear boundaries and is creating something new that did not previously exist. Large and small clinical trials can be classified as ‘projects’.

Project management can be described as having five steps:

• Controlling and monitoring
• Closing ​[5,6]​

These principles were initially developed for engineering and construction-based disciplines, but can easily be applied to academic research projects, pharmaceutical industry work[8] and, in particular, prospective studies, such as clinical trials ​[7]​ . By systematically applying the above project management principles, it is possible to eliminate costly mistakes, prevent budget overruns, improve quality and save time ​[8,9]​ .

There are very few clinical trials that have applied the principles of project management to guide and implement the full process from inception to completion. The Obsessive Compulsive Treatment Efficacy Trial (OCTET), funded by the NIHR, is one of the few studies to also investigate the application of research project management tools to the management of the trial. The purpose of this part of the study was to evaluate whether adoption of the main principles of project management would lead to successful completion and greater satisfaction for the staff involved in the day-to-day operation of the trial. It was concluded that developing trial management and methods was vital to the success of clinical trials ​[10]​ . Another example of the successful application of project management principles to a clinical study is the Alcohol and Pregnancy Project ​[11]​ . As part of this, the researchers comprehensively endorsed project management and agreed that it contributed substantially to the research outcome ​[11]​ .

In this article, the main principles of project management will be applied to research projects in health settings, using a clinical trial as an example of a complex project in a multi-centre setting.

Step 1: Initiation

The study proposal is the formal initiation of a clinical trial project. It gives the background for the research project and describes the transformation of the research question/hypothesis into an actual study.

The study proposal should include the following elements:

• What the trial is trying to achieve (i.e. objectives, the study intervention and the differences in treatment sought);
• Sample population;
• Eligibility criteria;
• Study intervention;
• Sample size;
• Differences in the treatment effects that are sought;
• How data will be collected;
• Data collection and analysis according to Good Clinical Practice guidelines;
• How the project will be monitored and controlled to ensure it is delivered on time;
• How the trial results will be reported and disseminated;
• Quality assurance to ensure reliable and reproducible results of the highest standards ​[6,12,13]​ .

Ethical approval must be sought at this stage and a steering committee set up, chaired by the principal investigator and others who will provide guidance and advice, but not be involved in the implementing of the project on a practical level. Finally, applications must be submitted to a funding organisation, which will give the green light for the next phase of the project.

Step 2: Planning

Formulate a clear project protocol that involves every aspect of the vision and scope of the project, including the day-to-day running of the trial. This is the most important phase of the project, as it allows the researchers and investigators to devise a clear plan on how to manage the process according to the scope of the study, within a designated timeframe and within budget. The major features of this phase of project management are:

• Study protocol;
• Study budget;
• Study manuals, documentation and software.

Study protocol

The study protocol is the plan of how the overall study will be managed by estimating a realistic time schedule of what can be achieved. It allows the investigators and all individuals involved to keep the project on time and within budget. The main features are:

• The timings for grant submission and grant approval;
• Site activation;
• Study participant recruitment;
• Data collection and data analysis;
• Outlining the timing and sequence of each major event within the study;
• The sequence of events required to meet the study objectives;
• Defining the persons responsible for activities and tasks;
• Establishing methods of communication between the steering committee and the independent data safety and monitoring committee.

Study budget

The main features of budgeting and costs for projects are:

• Estimating the budget and cost for each major milestone within the project lifecycle;
• Itemised budget for staff salaries (e.g. researchers, investigators, database programmers, statisticians);
• Site payment for contributing hospitals and study intervention costs;
• Contingency funds if events do not follow the protocol.

Study manuals, documentation and software

Study manuals ensure all staff receive the same training and make it more likely that staff will conduct the study in the same way — this is particularly relevant for clinical trials involving several sites (multi-centre trials). If drugs are being investigated in the study, a pharmacy manual is essential to specify preparation, storage, routes of delivery to the body and destruction. Finally, randomisation of study participants to different treatment arms in a confidential manner requires the use of software systems, which must be acquired and established.

Documentation relating to all aspects of the clinical trial is essential and should be recorded, monitored and archived in accordance with Good Clinical Practice (GCP) guidelines ​[13,14]​ . GCP is a quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the clinical trial data are credible. Source documentation includes the clinical history and medical records of all study participants before, during, and after the trial ends, records relating to staff training, handling of all drugs used, standard operating procedures, laboratory reports etc. This will ensure safety of study participants, accountability, and high-quality results. An audit in 2010 by the US Food and Drug Administration found that 6 out of 10 clinical trials did not keep adequate documentation ​[14]​ .

Step 3: Execution

At the execution stage of a project, the study plan is implemented and the clinical trial commences. The main features of this phase are:

• Teams are acquired and developed;
• Allocation of resources and support is provided to team members to ensure that assigned tasks are completed;
• Quality assurance is performed (see Step 4);
• Deliverables are developed and completed to meet the project’s aims and objectives;
• Communication links are established with the clinical teams and stakeholders (e.g. pharmaceutical companies, funders, regulatory agencies, study participants, research institutions);
• Research is conducted (e.g. analysing samples, synthesising and analysing data);
• Educational resources are disseminated to healthcare professionals, stakeholders and the general public ​[9,15,16]​ .

Step 4: Controlling and monitoring

This process occurs alongside the execution phase, focusing on measuring project progression and performance in line with previously agreed goals and timelines. The project plan specifies the quality assurance, control, monitoring and risk assessment of activities conducted while the clinical study is in progress. This includes, but is not limited to:

• Onsite monitoring and audits (e.g. looking through medical records and cross-checking data against case report forms);
• Reviewing the study manuals and files to ensure essential documents are up to date;
• Reviewing all manuals, including staff training manuals and standard operating procedures;
• Making sure research is conducted in accordance with GCP and Medicines and Healthcare products Regulatory Agency for research with human participants;
• Regularly reviewing the tasks and activities associated with each milestone;
• Data management (e.g. data checking, ensuring the data is void of errors);
• Interim data analysis;
• Safety monitoring ​[13,17]​ .

The outcomes of control and monitoring are compared to the original study plan and adjustments can be made if necessary.

A good clinical trial will have a contingency plan in place that was developed before the execution phase. It will specify the possible risks, the likelihood of them occurring, the potential impact on the project and the course of action recommended should they occur.

Step 5: Closing

Towards the end of a research project, the main activities involve:

• Final analysis of the data;
• Reporting of the data (e.g. presentations or a manuscript in a peer-reviewed journal);
• Closing of study sites;
• Informing ethics committee and trial staff of completion;
• Submitting final reports to funding bodies;
• Informing study participants of the completion of the clinical trial and the outcomes;
• Archiving records in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s good clinical practice guidelines, which state that all documentation should be kept for at least three years after completion of the clinical trial ​[13]​ .

In addition, a post-trial review might be conducted, in which management of the clinical trial is evaluated to determine strengths and weaknesses in the process, so that future clinical trials can be conducted more effectively ​[16]​ .

Role of the pharmacist in clinical trials

Pharmacists play a crucial role in clinical trial management, particularly in the areas of drug preparation, dispensing and management of adverse drug reactions. They are responsible for ensuring that the investigational drug is properly handled and administered to trial participants, and that any adverse events or drug interactions are documented and reported appropriately.

According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, pharmacists’ expertise is useful in the planning and conduct of clinical trials, particularly in the following areas:

• Investigational medicinal product management: preparation, labelling, storage, temperature monitoring, dispensing and accountability. This includes ensuring that the drug is handled and stored in accordance with the trial protocol and applicable regulations;
• Drug safety: monitoring trial participants for any adverse drug reactions or interactions and reporting these events to the study team and regulatory authorities;
• Compliance monitoring: pharmacists can help ensure that trial participants comply with the dosing regimen and other requirements of the trial protocol, and provide education and counselling as needed to ensure proper adherence;
• Quality control: general check of documentation, including informed consent forms and other legal documents;
• Data management: pharmacists are responsible for maintaining accurate records of drug dispensing and adverse event reporting, and for ensuring that these records are kept confidential and secure.

The success and failure of clinical trials

There are many challenges associated with managing clinical research projects. One of the main problems encountered in clinical trials, which has been cited repeatedly, is the difficulty of registering a sufficient sample size of patients in a timely fashion ​[18,19]​ . Trials that did manage to recruit successfully were more likely to have a dedicated trial manager ​[20]​ . Another challenge in multi-centre studies is identifying appropriate clinical sites and having realistic recruitment expectations. However, the main challenge is implementing and maintaining effective management systems and techniques in response to the needs of the project.

Box 2: Top tips to overcome the challenges of project management

• Define project scope: clearly define the scope of your project, including the goals, objectives and deliverables;
• Develop a project timeline: create a detailed project timeline that outlines milestones and deadlines for your project;
• Communicate regularly: establish regular communication channels with all stakeholders involved in the project, including team members, sponsors and other relevant parties;
• Monitor project risks: identify potential risks to the project and develop contingency plans to address them;
• Use project management tools: consider using tools such as Gantt charts, project management software and risk management tools.

Project management in health and medical research can substantially benefit both the managerial and scientific as­pects of clinical trial projects. Project management may also reduce a proportion of fund waste ​[21]​ . Staff that were part of the Alcohol and Pregnancy Project found that project management strategies improved communication and the integration of project work across multiple organisations and professions; helped them clarify and agree goals; assisted the delivery of defined project outcomes; and helped ensure accountability for results and performance[10]. Although this article has focused on the application of project management principles to clinical trials, these principles can be applied to any pharmacy project, whether research-related or not; for instance, clinical audits and quality improvement initiatives.

By using project management principles, pharmacists can ensure that their projects are completed on time, within budget and to the desired quality standards. In addition, using these principles allows pharmacists to enhance the quality and impact of their own projects, ultimately improving patient care and healthcare outcomes.

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What to know about project management for clinical trials.

Completing any multi-part task requires organization, coordination, and discipline — and, of course, clinical trials are no exeption. Planning a research study, launching a trial, and keeping things running smoothly requires knowledge and expertise, which is why clinical trial project managers are so vital to the process.

From creating a plan, communicating updates, calculating risks, and addressing any mistakes that arise , solid project management is a necessity to ensure medical research is allowed to move forward. Here, we’ll discuss the role of the clinical trial project manager, as well as tips for developing project plans, stakeholder involvement, communication, IRB submission, and summarizing lessons learned.

What is project management in clinical trials?

The Project Management Institute (PMI) defines project management as the "application of knowledge, skills, tools, and techniques to project activities to meet the project requirements." Project management combines expertise in scope, time, cost, quality, risk management, communication, and stakeholder management in order to move through the five basic phases of any project :

• Project initiation. This phase involves developing an idea, understanding the necessity of the project, and identifying the key decision-makers
• Project planning. This is the phase for making a plan and outlining the work required, including prioritization, budget, schedule, and resources
• Project execution. This is where tasks are distributed by informing all teams of their responsibilities and deadlines
• Project monitoring. This entails implementing project tracking to compare the current project status and progress with the original plan, adjusting as needed
• Project closure. The final phase, where project managers reflect on project success and key learnings for next time

When concerning clinical trials, project management brings all of these phases together to ensure set up, enrollment, operations, and reporting are all done smoothly and effectively. 

Roles of a clinical trial project manager

A clinical trial project manager may have different responsibilities specific to each trial, but in general, they will be tasked with vendor selection, budget oversight, IRB submissions, report creation, and meeting planning, all of which are detailed below.

Vendor selection: Because conducting a clinical trial requires many different elements, outside vendors will often be brought in to provide expertise in certain aspects of a study. This is most common for specialized elements such as Interactive Web Response Systems (IWRS) , electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment . Often, it will be the project manager's job to vet these vendors and assist with comparing options.

Timeline and budget oversight: Though every study begins with a specific timeline and budget, nearly 80% of all clinical trials are delayed due to difficulties in patient recruitment, which causes many to exceed their budget. In these situations, a project manager can leverage their expertise to hold the trial team accountable for the time and money spent on the study, in addition to managing expectations should these elements begin to change. 

IRB submissions: Any patient-facing materials involved in research studies must be reviewed and submitted for Institutional Review Board (IRB) approval, and gathering these materials is often the responsibility of the clinical trial project manager. Because every IRB is different, the project manager will need to look at previous submissions and any templates that are available to ensure the study's particular IRB requirements are met.

Report generation: As part of tracking the progress of a trial, clinical trial project managers should regularly generate and distribute reports on various aspects of a study’s progress. These reports can often be automated so they are not a time-consuming task, but they do play an essential role in keeping key stakeholders looped in on the progress of the research.

Meeting coordination: Occasionally, the trial’s key stakeholders may need to meet to review a trial’s progress and address any roadblocks. The project manager will likely be charged with planning and leading these meetings to ensure that all details are covered and relevant updates are provided.

Tips for effective project management in clinical trials

Create a detailed project plan

One of the best ways to circumvent delays and issues in a clinical trial is to create a detailed project plan before the study launches. This plan should include a timeline of milestones, key dates, a task schedule, and any other relevant pieces that can keep the project on track. Some people may prefer pen and paper for this, but there are also many online resources available to help project managers keep track of details and stay on schedule.

Anticipate risk management demands

Every project will have some level of risk, so it’s wise to acknowledge what points of contention may arise and plan accordingly. A few examples of risks associated with clinical trials include:

• Long wait times for IRB approval
• Delays in patient recruitment
• Turnover among site staff
• Changes to the trial protocol

Before the project starts, it can be helpful to come together as a team to discuss potential risks that may arise, share past experiences, and determine how they can be prevented or handled if they do arise.

Understand IRB requirements

In most studies, the project manager will also be tasked with gathering materials and submitting them for approval from the Institutional Review Board (IRB). Every IRB will vary on its guidelines, but IRB administrators should be able to answer any questions to ensure a smooth and efficient process.

Even if the responsibility of IRB submission is a task for the project manager, it can be helpful to enlist additional team members to provide a second set of eyes before the materials are submitted. It is also wise to create a checklist of elements that should be included in the IRB packet to ensure nothing gets left out.

Foster open communication between sites and sponsors

Another important communication piece for project managers is to share feedback from sites back with the sponsor of the trial. Communication is particularly important in relation to sharing updates with sponsors about recruitment or screening challenges the site may be facing. 

Communication tips for project management

One of the most important jobs of a clinical trial project manager is to ensure clear and effective communication with multiple stakeholders. To manage this communication from the onset, it can be useful to create a list of stakeholders, the updates they'll need, and how often they should be informed.

To manage this communication, the RACI project management method can provide a helpful framework to organize stakeholders into four categories based on their involvement in the project and communication needs.

• Responsible: The responsible party is the main point person for communication – this is the stakeholder who does the actual work of this part of the project. For example, when submitting outreach material to the IRB, the person responsible for creating the material may be the lead on the marketing team or the contact at a clinical trial recruitment company.
• Accountable: The accountable person is generally the manager of the responsible party and may wish to be involved in only some of the updates related to the project. Generally, if the responsible party needs approval from their manager, they should do so before sharing updates more broadly.
• Consulted: The consulted party would be any additional stakeholders who should weigh in on a project. The responsible or accountable party can generally help project managers determine who should be involved in the consultation.
• Informed: These are people who are simply kept up-to-date on the progress of the project at appropriate intervals.

A paper on managing clinical trials published by the National Institutes of Health also mentions the importance of keeping the investigators themselves in the loop about a trial, stating, "Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy." Because the investigators may also have busy clinical practices in addition to being part of the trial, it’s important to respect their time while making them feel involved and informed.

Project managers’ roles after a clinical trial

Project management is an ever-evolving skill and there are lessons to be learned from even the most successful project execution. It’s important that project managers evaluate each trial after it's complete in order to analyze trends and plan for the next one while key learnings are still top of mind. As Hubspot puts it, "a productive project post-mortem is a chance to fully unpack a project's trajectory and dig deeper into why things unfolded the way they did.”

Hosting a project post-mortem meeting involving key stakeholders is advisable. Sending a pre-meeting questionnaire can streamline the process of gathering thoughts on what went well, what didn't, and what could be done better next time. The agenda should include a recap of the project's goals and a review of the results so that any discrepancies can be addressed and everyone is able to come up with actionable takeaways for the future.

If you're interested in learning more about how Antidote begins the clinical trial recruitment process and manages the project throughout, download our recruitment template below.

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Effective Project Management of Clinical Trials

Feature article.

During medical school or post graduate training, we receive some formal training in designing and running complex programs like research projects or clinical trials. For those interested in clinical research, we then spend years learning how to ask good research questions, draft research protocols, apply correct research methodology and write successful grant applications.

Following this path, I was lucky to secure a grant and start a pilot clinical trial involving 30 patients. I thought I had all the right tools, time and resources to successfully conduct this project. However, I soon realized the painful reality of managing a clinical trial – it is incredibly challenging! I encountered multiple early failures like slow recruitment, lack of team coordination and overall inefficiency. It dawned on me that at no point during my clinical career had I received formal training in project management. A project management expert helped me navigate this challenge. In this article, I share my insights on project management not only for clinical trials but also for any type of project requiring the coordination of a team and resources around a specific objective.

Pearl #1: Project management of clinical trials is a science with valuable tools at your disposal. We tend to think the day-to-day business of managing a clinical trial is not the "scientific part." However, project management is a science and has well-defined evidence-based methods. Recognizing this is the first step in successfully managing clinical trials. Learning to harness the power of these tools is the second step. Using tools like chunking , GANTT charts , and resource allocation will organize and simplify the flow of your trial.

Pearl #2: Focus more on human aspects as compared to technical aspects. There are two major aspects of any large project: the technical and the human. As trained scientists, we tend to take the rational approach: "If I have two research nurses available and I am paying for 60% of their full time equivalent from my grant, then they will work whole-heartedly for three days per week on my project and I will finish this project in three months."

The root cause of inefficiency in my clinical trial was not technical, it was me ignoring the "human-side." I was fixated on productivity but overlooked the people working with me – my team. I realized that regardless of the resources and planning, it is the human element that drives successful project management.

• Grow the Team Leader: Building a better team always starts with building a better team leader. Inspiring your team with your hard work, work ethic, compassion, empathy and leading by example can ensure a long-lasting relationship even in challenging times. "Leading means that others willingly follow you – not because they have to, not because they are paid to, but because they want to." – Simon Sinek.
• Know your team: Ask, "What motivates my team to conduct research?" "What is their background, their perspective?" Have an honest conversation and get to know the person behind the title. For example, what motivates those trainees to volunteer their 80-hour work week and sacrifice their weekends to your project? What sparks the interest of your research nurses? Is it just a job requirement or are they passionate about the science? What are your team members' expectations? Answers to these questions will help you build a motivated, hard-working team. "A team is not a group of people that work together. A team is a group of people that trust each other." – Simon Sinek.
• Rapport building: Showing interest in your team member's life not only at work but also outside work helps to create a stronger relationship. While we have multiple project meetings where we discuss progress, timelines and feedback, taking an interest in the person behind the job is essential. Asking about their family, hobbies and how their weekend was is enough to create a connection. A big part of being a scientist is being a good friendly human being first.
• Feedback: It is important to get feedback from team members and always get their input on how to improve workflow and identify gaps between your expectations and their perception. It provides the opportunity to look at things from their perspective and realize their challenges.

Conclusion Project management coaching made me realize that although I was technically competent, I was ignoring the human element of my clinical trial. What did I change? I got to know my team members as individuals. I discovered what motivated each one of them and we worked together to align their roles in light of their strengths and interests. They were helpful in suggesting several quality improvements to the project and our overall workflow and efficiency was much better. I went from frazzled to effectively managing my first clinical trial.

In the end, real life is a lot messier than a mathematical equation. To successfully move a project, program or trial forward, designing it is not enough: plan using the right tools, keep your key stakeholders motivated and informed, and channel your energy into growing a solid team.

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This article was co-authored by Zain Asad, MD, Fellow in Training (FIT) at the University of Oklahoma in Oklahoma City, OK, and Kat Niewiadomska, PhD, ACC Member Leadership Development associate.

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Home / Insights / Project Management Framework and Tools in Clinical Trials

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Project Management Framework and Tools in Clinical Trials

September 29, 2020

Project management’s maturity as a discipline has had wide-reaching effects across most industries.

It’s changed the way people manufacture products, develop software, plan company strategies — and even how clinical trials are conducted.

Here, we explore how the evolution of project management has impacted clinical research, and what aspects of project management trial leaders need to know to be successful.

Meet Your Clinical Project Manager

Because clinical trials have so many stakeholders and moving parts, it makes sense that someone should take responsibility at a project level.

As Genesis Research Services Business and Clinical Research Manager  Dom Bailey  points out, this person — the clinical project manager — is responsible for explicitly laying out the project objectives, scope and stakeholder management plan.

Additionally, the project manager will work with a CRO’s leadership team to ensure things like sufficient recruitment numbers and that the necessary project management tools are in place.

Dalfoni Banerjee  at 3Sixty Pharma Solutions says a good clinical project manager must be able to plan and establish key metrics, communicate very well, and remain oriented on the project’s goals while maintaining flexibility to accommodate any unexpected changes.

For trial leaders, perhaps the most important trait in a project manager is their communication skills. “Nothing is worse than working for an out-of-touch project manager—someone who is lost in the project plan or the study metrics, or making assignments without listening or making any kinds of assessments or mid-course corrections,”  Jim Moat  at IMARC Research writes.

“Someone with a balanced view of the big picture and the smaller, but important, details, is bound to lead a more successful project and team.”

Moat underscores how important relationships are in managing a trial, which means a good PM knows how to listen and is willing to spend time with research staff to understand realities on the ground.

Zain Asad, M.D., and Kat Niewiadomska, Ph.D. , write for the American College of Cardiology that their own experience with project management made them better team members. The PM perspective allowed them to see how each person complemented others and fit into a cohesive team.

The Rising Influence of Agile Project Management in Clinical Trials

Nearly 20 years ago, the  Agile Manifesto  laid out a new framework for developing software by making the production process iterative and dynamic.

Today, that methodology has found purchase across industries, and its principles are nudging clinical project management into new directions.

Most clinical project managers apply agile frameworks in an effort to cut costs and improve efficiencies. That said, aspects of agile such as iterative development and regular opportunities for stakeholder feedback create other opportunities in clinical trials.

As  Syneos Health  notes, an agile approach to clinical trial management can:

• Break up siloed teams and facilitate cross-functional cooperation.
• Upend linear business processes and replace those with opportunities to innovate.
• Center stakeholder needs.
• Facilitate “early and proactive dialogue with regulators to support expedited pathways for bringing new products or innovation to market.”

As promising as that all sounds, though, agile’s uptake has been stifled on a few fronts. In a 2018 dissertation for Harrisburg University of Science and Technology,  Jitendrakumar Narola  surveyed nearly two dozen healthcare IT professionals about their experience with agile projects in clinical trials.

Narola’s research found that many respondents were hesitant to embrace an agile approach to project management because they didn’t feel sufficiently familiar with the framework, or because they weren’t sure how compatible it would be with FDA regulations.

Further, agile transformations are more fundamental undertakings than simply tweaking how a project is managed. “[A]gile methodology is not applicable neither to all parts of a study nor to all kinds of studies, but striving for an agile transformation in an organization as a whole will pave the way in making clinical trials as ‘adaptive’ as possible,” researchers  Katarina B. Pavlović, Ivana Berić and Ljiljana Berezljev  write in the European Project Management Journal.

This, of course, speaks to a larger movement among researchers who lean on  adaptive trial designs  to make data collection and analysis concurrent during an in-progress trial.

The Tools Shaping Clinical Project Management

The fundamental tasks of project management are the same, no matter the industry or the project.

A clinical project manager will specifically need a tool to help with:

• Creating the work breakdown structure.
• Analyzing and mitigating risks.
• Planning budgets.
• Determining milestones and key metrics to track.

This is the kind of work that can be done in a  clinical trial management system  (CTMS). A CTMS should give you space to organize an electronic trial master file (eTMF), which is absolutely crucial in what Jim Moat at IMARC describes as “telling the story of your study.”

“Ensure your trial master file is kept current and complete,” he writes. “ … Make judicious use of notes-to-file and memos to document unusual steps taken in a given situation. As we say at IMARC, ‘you’ve done the work; now write it down to take credit for your work.’”

Further, ensure your CTMS allows you to share documents (or at least integrate with a tool like  Microsoft SharePoint , which facilitates document collaboration), and that it provides a place to track timelines and milestones.

From there, a project manager might opt for a separate project management platform that accommodates their preferred methodology. For example, a tool like  Asana  or  Microsoft Project Manager  can help visualize timelines, budgets and tasks.

Or, if the project manager needs to organize work in a Kanban-style workflow, tools like  Trello  or  MeisterTask  can help visualize those tasks.

Finally, a project manager needs to be able to host and lead meetings, sometimes with remote staff. In such cases, a conferencing tool like  Zoom  or  GoToMeeting  would be useful.

With the tools above and a framework in place, a clinical project manager has what they need to try to steer a clinical trial toward its goals within budget and within expected timelines. Of course, no projects go exactly as planned, so transparency and communication go a long way to getting a trial back on track in the face of unexpected changes.

For clinical trial leaders, having this kind of perspective into the project-management aspects of a trial will be useful in marshalling resources and leading teams as needed.

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PM Tips & Ideas

The Role of Project Management in Clinical Research

by Daniel Linman · Published April 14, 2023 · Updated June 26, 2023

Clinical research project management is a critical and integral component of science-heavy industries, such as pharmaceuticals and biomedicine, to ensure that time and money are mastered wisely and all research requirements are met.

In a clinical project, the research team applies various project management tools and techniques to ensure a balanced approach between the technology and human resources required to complete the project and ensure patients’ safety in clinical trials.

In addition, the clinical project manager ensures that the research is carried out in compliance with the rules and regulations of the host country and the ethical and informatics guidelines set by relevant scientific and professional organizations, such as CDISC, Health Level 7, DICOM (ISO 12052), Institutional Review Board (IRB), and more.

This guide will present the definition and role of the project management process in clinical research and its effect on the healthcare industry as a whole. We will also explore the hurdles clinical trial project managers must overcome and how the gained benefits improve the whole process.

Clinical Trial as a Project

The fundamental definition of a project is “a challenge or effort that requires time and coordinated effort to complete, especially one that is elaborate or not entirely routine.

The same can be extended to a clinical trial or study, as it requires the effort and expertise of several individuals to achieve the set objective within a definite time frame, no matter whether the research project lasts ten months or 15 years, for example.

The  National Institutes of Health  defines a clinical trial as a “research study” to answer specific questions and solve a particular problem relating to the development of new medicines, vaccines, surgical procedures, therapies, methods of diagnosis, and other types of biomedical interventions.

In a clinical trial, researchers conduct objective scientific studies to determine how well an investigational product works and how safe it is for patients. They employ a project-based approach (an in-depth exploration of a problem through a scientific experiment or series of tests) and use project management tools like the  critical path analysis  and Gantt charts to schedule, manage and control various resources and activities in a timely and cost-effective manner.

In the process, the research team develops a hypothesis and action plan, then proceeds to collect information and make observations. As a result, they gain valuable data that solves problems and answers questions. Afterward, the team presents its findings in a report to the appropriate regulatory authority for review.

The results can be achieved only following the line of step-by-step development from a start time to an end time.

The following characterizes a clinical trial as a project :

• Progressive elaboration (the results can be achieved only following the line of step-by-step development from a start date to an end date).
• Focus on objective and measurable results.
• Every clinical research follows a unique set of requirements defined within time, budget, scope, and technology boundaries.
• Protocols, procedures, and regulations to ensure safety, efficiency, and effective use of resources.

Hence, clinical research project management ensures the whole research process is carried out within time, budget, and technology boundaries, and within regulatory requirements. This role combines “planning, budgeting, prioritizing, and controlling” to ensure the release of a clinical trial product in compliance with all the requirements and regulations.

The Need of Project Management in Clinical Research

Now that we understand what clinical research is, it’s time to explain why we need  project management in healthcare  and medicine.

Research and healthcare organizations are constantly searching for ways to offer the best patient care possible. However, introducing new treatments and drugs is highly complex and time-consuming. Therefore, careful coordination and planning are vital to ensure the research process is carried out successfully.

This is where project management techniques come into play, offering research organizations the framework and support necessary for effective resource allocation,  risk management , and timely execution. Ultimately, clinical trial project management is the key to successful implementation and the fruition of new drugs and treatments within the healthcare sector.

That said, the project management process not only helps the research organization with any difficulties it may encounter in its daily activities but also:

• Provides a framework for efficiently planning, allocating, and controlling resources
• Ensures the patient’s safety in clinical trials
• Guarantees compliance with the rules and regulations and ensures patients’ and staff’s safety in clinical trials (e.g., through an IRB submission).
• Improves research yield in clinical trials and studies
• Assures project success by identifying risks, problems, and issues earlier.
• Structures and coordinates the activities of various scientific and professional specialists.
• Provides an efficient monitoring system to ensure timely progress, tracking, and reporting throughout the clinical trial process.

Clinical Trial Budgeting

Medical laboratories and research firms rely on the project management process of clinical trial budgeting to maintain a healthy financial equilibrium. Project management ensures that trial budgeting is accurate and effective, reducing mistakes and saving time.

However, this process can be very confusing, especially when dealing with a new client and research project. For prospective clients, the learning curve can be steep, and the assistance of a professional project manager is invaluable. In addition, a good project manager will work with you to plan, manage and control your trial budget.

The process starts with a detailed needs analysis. The needs analysis will thoroughly discuss the objectives, resources, schedule, and budget required to complete the trial. The result is a “ clinical trial budget ” specific to your medical research.

The next step is to conduct some initial trial cost analyses and perform detailed pre-project planning, which involves calculating the costs of developing the actual trial. This pre-project planning will either be conducted by the project manager or a consultant.

The results of the pre-project planning are used to develop a clinical trial budget, which is the amount of money required to complete the trial. This budget will be broken down into categories based on cost drivers or classes that need the same type and amount of resources.

The next stage is to conduct a risk assessment to determine if the trial budget is feasible and valid. During this process, the cost drivers are reconsidered to ensure that cost estimates are consistent with the project plan.

Finally, a statement of work is developed that outlines the stages and timing of the trial research. This statement of work details the objectives and strategies, allocates responsibilities for each task, and identifies the resources required to complete each stage of the trial research.

The main benefit of developing a clinical trial budget is that it helps you to maintain a healthy financial balance. In addition, the process of clinical trial budgeting is designed to help improve your accuracy and effectiveness, reduce errors, and save time.

Challenges Faced by Clinical Research Project Managers

Managing clinical trials and experiments is a delicate balance between clinical research and project management, as it demands a thorough knowledge of medicine and pharmaceuticals and a practical understanding of project management.

Clinical research project managers must always comply with the following:

• Regulatory Compliance : Healthcare organizations must adhere to the ever-increasing number of regulations, including but not limited to the  Health Insurance Portability and Accountability Act  (HIPAA) and the Affordable Care Act (ACA). Project managers must ensure that their projects comply with these regulations to avoid potential fines or penalties for the organization.
• Rapidly Changing Technology : The healthcare industry continuously adopts new technologies, making it difficult for project managers to stay current on the latest advancements and best practices.
• Interdisciplinary Collaboration : Clinical research projects often involve various stakeholders, such as physicians, nurses, administrators, and IT professionals, who may have different priorities and goals. Project managers must navigate these complexities and foster collaboration to achieve project success.
• Resource Constraints : Research and healthcare organizations often operate under tight budget constraints, which can impact the available resources for project management. Project managers must effectively allocate limited resources to ensure projects are completed on time and within budget.

The Benefits of Clinical Research Project Management

As stated above, the clinical trial project management process provides a framework for efficient resource allocation while optimizing time and financial resources. The principal benefits of this approach include the following:

• Improved patient satisfaction . The benefits to patients are directly related to the quality of care they receive during clinical trials and studies. The project management approach allows research organizations to gain information to improve the patient’s treatment and care.
• Increased clinical trial productivity . Waterfall project management methodologies like PMBOK® Guide allow research teams to allocate their resources most efficiently, ultimately leading to a timely and successful clinical trial and study completion.
• Increased credibility . The clinical research and study management process allows for the creation of a credible body of evidence to demonstrate the outcomes of a proposed clinical trial. It helps confirm and validate results, thus increasing the credibility of the research.
• Reduced risk . The application of project management in medical research allows the research staff to identify any troubles early on, which in turn helps them develop plans and strategies to mitigate those risks and uncertainties.
• Increased visibility . The clinical trial and study management process ensures that all the processes, procedures, and tasks involved in a clinical trial or study are adequately organized and carried out. This process also allows for the creation of concise reports to demonstrate the outcomes and provide relevant information to increase visibility for stakeholders.

Implementing effective project management in clinical research requires an organization to consider training for their team members, even at a basic level, through  online training , local classes, or bringing in an external trainer. It’s about more than meeting objectives and delivering projects on time. It’s about improving all aspects of the research process by adopting new technologies and operational approaches. Cost savings become possible when avoiding waste and streamlining operations.

Applying project management to biomedical research is a step towards efficiently managing clinical trials and experiments. It aims at providing knowledge about best practices in planning, tracking, and controlling projects. The benefits are significant and comprehensive, as it improves the delivery of healthcare services and lowers the risk of errors.

Daniel Linman

Daniel is a business analyst for a Canadian software company. He has worked on various IT projects but is most interested in systems architecture and software development. In his free time, Daniel enjoys playing the guitar, loves going for hikes, and spending time with his family.

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REVIEW article

Project stakeholder management in the clinical research environment: how to do it right.

• 1 Department of Population Health, New York University Medical Center, New York, NY, USA
• 2 Department of Management, Zicklin School of Business, Baruch College, New York, NY, USA
• 3 District Mental Health Programme, Madurai Medical College, Madurai, India
• 4 Division of Community Psychiatry, M. S. Chellamuthu Trust and Research Foundation, Madurai, India
• 5 University of Virginia Darden School of Business, Charlottesville, VA, USA
• 6 Department of Neuropsychiatry and Behavioral Science, University of South Carolina School of Medicine, Columbia, SC, USA
• 7 University of South Carolina, Columbia, SC, USA

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK ® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

A true architect is not an artist but an optimistic realist. They take a diverse number of stakeholders, extract needs, concerns, and dreams, and then create a beautiful yet tangible solution that is loved by the users and the community at large. We create vessels in which life happens

– Cameron Sinclair ( 26 )

In recent years, a revolution in thinking about organizational management and decision making has taken place. Increasingly, programs have been incorporated into organizations, typically private sector corporations or government agencies, which have sought to involve “stakeholders” in management decision making. Stakeholders are the customers, suppliers, the general public, and any other group, which are likely to be affected by the organization’s ultimate decisions. The process of incorporating the ideas and input from these groups has been termed “stakeholder engagement.” It reflects an increasingly accepted attitude that organizations not only have an ethical obligation to involve the participation of stakeholders in their collective activity but also in so doing their overall organizational effectiveness will be enhanced. While certain generalizations in the application of this philosophy are constant, minor variations also exist, which reflect the specific goals that the organization is pursuing. In this review, the application of stakeholder engagement in clinical research settings, particularly in hospitals or university research centers, is considered.

According to the Institute of Medicine (IOM), the purpose of comparative effectiveness research (CER) is, “to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve healthcare at both the individual and population level” ( 1 ). The Kellogg Commission report defines engagement as follows: “By ‘ engagement ’ we refer to institutions that have redesigned their teaching, research, and extension and service functions to become even more sympathetically and productively involved with their communities, however, community may be defined” ( 2 ). Hospitals and research centers are increasingly taking deliberate steps to include their broader constituencies in project management decision making and to seek their input at an early stage of the research or program implementation process. The term “ community engagement ,” can be defined as, “the process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people” [( 3 ), p.3]. It has been noted that traditional models of research which view study subjects or targets of program development as passive audiences may result in research findings that are poorly aligned with the information needs of real-world decision makers ( 4 , 5 ). An additional impetus for this interest has been the Patient Protection and Affordable Care Act of 2010, which was enacted to promote patient engagement. The purpose of the act has been to help patients, clinicians, purchasers, and policy makers make better informed health decisions by “advancing the quality and relevance of evidence about how to prevent, diagnose, treat, monitor, and manage diseases, disorders, and other health conditions.”

The key focus in the process of stakeholder engagement is of course the stakeholder. Freeman ( 6 ): 46 defined stakeholder as, “any group or individual who can affect or is affected by the achievement of the organization’s objectives.” According to the project management institute (PMI), the term stakeholder refers to, “an individual, group, or organization, who may affect, be affected by, or perceive itself to be affected by a decision, activity, or outcome of a project” ( 7 ). In other words, almost any individual or group of individuals with an interest or stake in a consensus-building process thereby the outcome of the project and/or an ability to exert a positive or negative influence by the execution or completion of a project or being affected by the work or its deliverables, outputs, or results.

In clinical research, researchers are often faced with questions about the choices that must be made by patients. Research can also be focused on assisting the process of program development. In either instance, the underlying motivation remains the same: to healthcare delivery, to become aware of dysfunctionalities that may exist in healthcare, and to improve the outcomes of proposed changes. It is essential then that research and program processes are assisted by those who are most directly affected by proposals, i.e., the patients themselves. Central to the process of encouraging stakeholder involvement therefore is a basic assumption that patients have the right to make the best decisions about their own health care.

Stakeholder engagement versus stakeholder management (ShM): in recent years, the term “ stakeholder engagement ” (ShE) has become widely used in applied clinical research and new program development. An important reason for this is that it has been repeatedly shown that critical health issues, which are often known to the patients or research subjects themselves, may not have been addressed in the original research or program proposals ( 8 ). Stakeholder engagement is a bidirectional process. It begins when the researcher communicates and interacts with stakeholders, and ultimately results in informed decision-making concerning the selection, conduct, as well as dissemination of research findings in order to achieve a desired outcome and enhance accountability ( 9 , 10 ). Stakeholder engagement is thus differentiated from one-way communication processes that seek to influence groups to agree with a decision that has already been made.

The obligation to serve all stakeholder interests is often called stakeholder management ( 11 , 12 ). The main distinction between stakeholder management and stakeholder engagement largely rests on the extent to which stakeholders are involved in the decision-making processes. The process of engagement varies across different research programs, but is highly noticeable in complex, multidisciplinary research.

A stakeholder analysis is a process, which provides insights into, and understanding of, the interaction between a project and its stakeholders. In other words, the process of listing, classifying, and assessing the influence of these stakeholders in a project is termed a stakeholder analysis. Stakeholder analysis systematically gathers and analyzes both qualitative and quantitative information thereby to determine whose interest should be taken into account throughout the project. One of the first tasks that a clinical project manager must undertake is to identify how stakeholders can make the greatest impact on the research project or program change, which is being contemplated. The function of stakeholder analysis is to produce an awareness of who will be affected by the project and who can contribute to making the project more successful. The stakeholder analysis, which is usually undertaken at an early stage of planning, is an integral part of risk and reward assessment activities.

It is essential for maximal project effectiveness that managers be committed to the basic philosophy of stakeholder involvement. Project managers must communicate and impart what they see as their goals but also seek to encourage participation by stakeholders so that their perspectives are included in decision making.

The process of identifying, engaging stakeholders must begin well in advance so that dialog is seen to play an important part of project implementation; no decisions should be already made before commencing stakeholder engagement on project-related issues.

Benefits of Stakeholder Engagement

Well managed projects, although long and complex, create long-term economic gain and social values meaning that proper use of taxpayer’s money. When done correctly, stakeholder engagement provides opportunities to further align clinical research practices with societal needs, values, and expectations, helping to drive long-term sustainability and stakeholder interests.

Stakeholder engagement is intended to help administrators fully realize the benefits of applying community and patient interest in hospital programs, and to ensure that research and program changes benefit those who are most directly affected.

The stakeholder focus group is a communication medium through which the opinions of individuals or groups of individuals who are impacted by the research can be elicited. Focus groups can also serve to clarify each stakeholder’s role and responsibilities, as well as promoting an overall understanding of the project requirements. Such processes also provide stakeholders with an environment in which they can express their opinions and feel that they have been heard.

In a series of related manuals the Patient-Centered Outcomes Research Institute (PCORI) ( 13 ) has provided a group of examples of how hospitals and medical clinics can encourage stakeholder involvement, in various research projects or programs whose aim was to improve the quality of medical services.

It can be seen from one of our case studies (see Appendix) that stakeholders can make meaningful contributions to a project when opportunities are structured to encourage their participation. The process of encouraging stakeholder participation is referred to as stakeholder management.

Requirements for Stakeholder Management

Stakeholder management involves the processes of identifying (both internal as well as external) stakeholders; assessing stakeholders’ skills, knowledge, and expertise; determining stakeholders’ requirements; determining stakeholders’ interests and expectations; determining stakeholders’ communication needs; addressing stakeholders’ issues and concerns as they occur; maintaining a positive relationship and communicating with stakeholders throughout the project; identifying stakeholders’ influence-controlling strategies; making sure that stakeholders are involved in the project at the required level throughout the project; and confirming continuous interactions with the stakeholders. In the area of clinical research patients and other stakeholders such as physicians, clinicians, nurses, and others have critical roles to play. Clinical researchers at the outset of research need to ask for patient participation in the development of research questions. Researchers need to find out the exact characteristics of study participants and to define what the nature of the research outcomes should be. In this process, contributions from patients are helpful and often critically important for project success. The process of carrying out research also involves measuring the results of research interventions and monitoring the progress of the research, especially in terms of whether or not it is being directed toward the initial intentions of the research. Finally, patients, who are often very closely connected with the target populations of the research, have a direct perspective on how the targets of the research will respond to the research recommendations, and therefore, can provide useful inputs for insuring its relevancy.

Project Stakeholder Management Processes

The PMI identifies four key processes that are associated with the stakeholder management knowledge area in initiating, planning, executing, and monitoring and controlling process groups ( 7 ) (Table 1 ).

Table 1 . Four project stakeholder management processes and key outputs .

Identify Stakeholders

This entails identifying all people or organizations impacted by the project and documenting relevant information regarding their interests, expectations, involvement, and influence on project success. In the hospital setting, the stakeholders are usually the patients, but can also be healthcare professionals and the families of patients. Examples of stakeholders are given in Table 2 .

Table 2 . The stakeholders can be categorized or classified in many different ways for different purposes .

Throughout the project the following critical tasks should be carried out.

All internal and external stakeholders should be identified. These will usually be the patients but often will include the patients’ family members, healthcare providers, or program administrators.

Stakeholders’ interests, requirements, and expectations should be identified. Obviously, patients are interested in the effects of proposed program changes or research outcomes on their health and well-being, but may have additional interests such as hoping to improve their employment prospects, or expanding their range of capabilities. Clinical researchers and administrators should be alert to these concerns and take appropriate steps to address them. It has been found, for instance, that stakeholder views at the beginning of a program evaluation process may be provisional or may change as a result of additional information. Additionally, stakeholders’ interests may change over time. In one study, the results of pre-workshop and final workshop voting often differed, suggesting that prioritization efforts relying solely on requests for topics from stakeholder groups without in-person discussion may provide different research priorities ( 14 ). Thus, efforts should be made to audit the evolving nature of stakeholders’ expectations and preferences through structured methods.

All stakeholders’ levels of influence should be determined. It is often the case that patients and other beneficiaries of program development have talents and skills that may not be reflected in records of formal education or social standing. Certain personal traits, which patient stakeholders may possess, such as communication skills or life experience, could nevertheless prove invaluable for achieving project goals.

A communication plan for the stakeholders should be determined. Patient stakeholders may not always be familiar with or comfortable in using traditional channels of communication in large organizations. As noted by Lavallee et al. ( 15 ), the increasing availability of mobile technology, social media, internet venues, and electronic devices has multiplied the communication options for many, but carries with it the risk of increasing the quantity of participants while reducing the depth of involvement. Often, the use of focus groups or small informal meetings can be used to increase the quality of communication or to elicit participation from those who might otherwise be reticent about expressing their views. Reviews of methods of communication for engaging stakeholders have concluded that a combination of approaches probably yields the best results. Methods such as voting or using ranking procedures such as the analytic hierarchy process ( 16 ) and other structured techniques are best for establishing research priorities, whereas in-person methods are best for clarifying ideas and generating ideas ( 17 ). Repeated exposure to these experiences be useful for identifying patient stakeholders’ core concerns and for acclimatizing them to organizational communication.

Stakeholders’ expectations and influence over the project should be managed. Reality checks are important for balancing patients’ idealistic expectations and the necessity of dealing with the challenges of getting things done through institutions. Program administrators must identify patient stakeholders’ strengths and channel these for optimal organizational impact.

Depending on their complexity, size, and type, most projects have a diverse number of internal and external stakeholders at different levels of the organization with different authority levels.

Stakeholder identification is a dynamic and sometimes difficult process, and the influence of a stakeholder may not become evident until later stages of a project. And, sometimes projects evolve so that solving unseen problems emerges as a critical task. It is essential to identify as many as stakeholders as possible at the beginning of the project and classify them according to their level of interest, influence, importance, and expectations at the earliest stages of the project as much as possible (Table 3 ). The identification of the relevant stakeholders is not only a core necessity but also poses a significant challenge. For example, under cost constraints, it might not be possible to identify all external stakeholders ( 18 ). On the other hand, stakeholders who are missed out during the identification process might have special requests to be fulfilled. This could potentially delay the project completion or escalate the cost as their requirement needs to be fulfilled. Additionally, as Bryson ( 19 ) pointed out that the failure to attend to the information concerns of stakeholders clearly is a kind of flaw in thinking or action that too often and too predictably leads to poor performance outright failure or even disaster.

Table 3 . Stakeholder management strategy .

As per the PMBOK ® , the “Identify Stakeholders” process has the following inputs, tools and techniques, and outputs:

Project Charter

The project charter gives an overall picture of the project as well as describing some of the stakeholders and their interest in the project along with their requirements.

Procurement Documents

If a project is based on an established contract or the result of a procurement activity, the parties in that contract are key project stakeholders. Other relevant parties such as suppliers, legal parties, and people who will execute the contract should also be considered as part of the project stakeholders list.

Enterprise Environmental Factors

Hospital culture and structure, and other factors may influence the identify stakeholders process.

Organizational Process Assets

To benefit from previous experience those in charge of developing proposals should carefully review the efforts of earlier projects. The stakeholder register template, lessons learned, and the stakeholder registers from previous projects may influence the identify stakeholders process.

Stakeholder Analysis

It is not possible to treat all stakeholders equally in the project, and they are given different priorities with respect to their interests, expectations, and influence on the project. Stakeholder analysis is a process of systematically gathering and analyzing all relevant quantitative and qualitative information about the stakeholders in order to prioritize them and determine whose interests should be taken into consideration throughout the project.

As per PMI, stakeholder analysis is performed by the following steps:

Step 1: all potential project stakeholders and their relevant information, such as their roles, interests, knowledge levels, expectations, and influence levels should be identified.

Step 2: the potential impact or support each stakeholder can contribute should be identified. As per the PMBOK ® , there are several classification models below:

• Power/interest grid: this is based on the level of authority or power and the level of concern or interest that a stakeholder has regarding the project outcome (Figure 1 ).

• Power/influence grid: this is based on the level of authority or power and active influence a stakeholder has.

• Influence/impact grid: this groups stakeholders based on their involvement or influence and their ability to affect changes to planning or execution (impact).

• Salience model: this addresses a stakeholder’s power or ability to impose their will, urgency, or need for immediate attention from the team and legitimate involvement in a project.

Step 3: in order to influence the stakeholders to enhance their support and to mitigate potential negative impacts, the way in which key stakeholders are likely to react or respond in various situations should be assessed.

Figure 1. Stakeholder mapping: the power versus interest grid . The gird shows stakeholders on a two-by-two matrix showing the strategies to be employed to engage and manage them. Power/interest grid model shows the grouping of the stakeholders based on their level of authority (“power”) and their level or concern (“interest”) regarding the project outcomes. Identifying and classifying the stakeholders is pivotal as it helps to develop appropriate strategies to effectively engage and manage all the stakeholders involved in a particular project. This also provides a clear-cut strategy and action-oriented and workable plan to interact with the all the stakeholders in an effective manner so as to minimize the resistance and maximize the support. A project is as successful as the stakeholders think it is. The details of power versus interest grids are found elsewhere ( 25 ).

Stakeholders who have greater power or influence and a strong interest in the project should be managed closely and continuously updated. Stakeholders who have significant power but low interest in the project should be kept informed about the project. Stakeholders who have low power and low interest should be monitored, and stakeholders who have low power and high interest should be kept satisfied.

Expert Judgment

Judgment and expert opinions can be gathered to identify stakeholders, usually from the senior management. These resources can include project team members, project managers from similar projects, subject matter experts, industry groups and consultants, and other units within the hospital or research setting.

Profile analysis meetings with team members and the sponsor will be beneficial for identifying stakeholders and their knowledge, potential roles, importance, impact, interest, and expectations in the project.

Stakeholder Register

This contains all details related to the identified stakeholders including but not limited to

• Stakeholder classification: stakeholders can be classified in many different ways. For example, primary (users of the products, services, or results) or secondary (may not be the direct users, but have some influential relationship), Internal/external, neutral/resistor/supporter/hard to hear, and so on.

• Identification information: name, title, location, organization, role in the project, position, and contact information.

• Assessment information: key requirements and expectations, potential impact, importance, and influence on the project.

A project manager may publish the stakeholder register with other project documentation or keep it in reserve for personal use only (Table 4 ).

Table 4 . A snapshot of a stakeholder register: stakeholder register is a project document, which is an output of identify stakeholders process .

Plan Stakeholder Management

The plan stakeholder management process defines an approach for managing stakeholders throughout the entire project life cycle as per their interest, impact, importance, and influence over the project. It defines the strategies for building close relationships with stakeholders who can benefit the project and for minimizing the influence of stakeholders who may have a negative impact on the project.

This process is iterative and should be reviewed on a regular basis as the required level of engagement of the stakeholders’ changes in the project.

As per the PMBOK ® , the Plan Stakeholder Management process has the following inputs, tools and techniques, and outputs:

Project Management Plan

Components of the project management plan (PMP) such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in developing the stakeholder management plan (SMP).

This contains all details related to the identified stakeholders, including identification information, assessment information, and classification.

All environmental factors within the hospital or clinical research facility, including its culture and history of the organization, are used.

All organizational process assets, especially lessons learned and historical information are used.

Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify the level of involvement required from each stakeholder at various stages of the project. However, it is possible that expert judgment can be mistaken when possible expert judgment must be balanced with input from the stakeholders themselves.

Meetings with team members and the sponsor will be beneficial for identifying the level of engagement required from each stakeholder.

Analytical Techniques

Various analytical techniques are used for identifying the required level of stakeholder engagement. These techniques take into consideration stakeholder sensitivity to project goals and personal orientations such as being unaware, resistant, neutral, supportive, or providing leadership.

Stakeholder Engagement Assessment Matrix

The stakeholder engagement assessment matrix (SEAM) is used to assess the current and desired state of engagement of a stakeholder for the current phase of the project (Table 5 ).

Table 5 . Stakeholder engagement assessment matrix (SEAM): please note that the current and desired engagement level of key stakeholders expect to change as the project progresses and develops .

The SEAM illustrates that only Stakeholder 4 is engaged in the project at the desired state. The project manager should consider additional communication and further actions to bring all other stakeholders to the supportive and leading states.

Stakeholder engagement is critical to project success; thus, required actions and communication should be planned to minimize the gap between the desired level of engagement and the actual level of engagement.

Stakeholder Management Plan

Stakeholder management plan, which is a subsidiary plan of the PMP that defines the processes, procedures, tools, and techniques to effectively engage stakeholders in project decisions and execution on the analysis of their needs, interests, and potential impact ( 7 ). The SMP can be formal, informal, highly detailed, or broadly framed based on the needs of the project. The SMP typically describes the following:

• information needs of each stakeholder or stakeholder group;

• stakeholder communication requirements;

• format, method, time frame, and frequency for the distribution of required information to the stakeholders;

• person responsible for communicating the information to the stakeholders;

• methods of refining the SMP;

• required engagement level of the stakeholders at various stages of the project;

• stakeholder management strategy that defines an approach to manage stakeholders throughout the entire project life cycle. It defines the strategies to increase the support of the stakeholders who can impact the project positively and minimize the negative impacts or intentions of the stakeholders who can negatively impact the project.

The portion of the plan that contains sensitive information such as stakeholders’ personalities and attitudes, negative impact that stakeholders may cause, or other factors is not usually published and is kept in reserve by the project manager for personal use only.

Project Documents Updates

Project documents such as the project schedule, stakeholder register, and others may be updated.

Manage Stakeholder Engagement

The Manage Stakeholder Engagement process is focused on meeting and exceeding the stakeholders’ expectations by continuously communicating with them, clarifying and resolving their issues, addressing their concerns, and improving the project performance by implementing their change requests.

As per PMI, the project manager is responsible for managing the stakeholders’ expectations. Meeting the stakeholders’ expectations increases the probability of project success by enabling the stakeholders to be active supporters of the project, drastically reducing unresolved stakeholder issues, and limiting disruptions in the project.

As per the PMBOK ® , the Manage Stakeholder Engagement process has the following inputs, tools and techniques, and outputs:

Within the research context, the SMP identifies information needs, communication requirements, required engagement level at various stages of the project, stakeholder management strategy, and other factors to identify and manage stakeholders throughout the entire project life cycle.

Communications Management Plan

The communications management plan is a subsidiary of the PMP. It can be formal, informal, highly detailed, or broadly framed based on the needs of the project. The communications management plan typically describes the following: purpose for communication; Information needs of each stakeholder or stakeholder group; stakeholder communication requirements; format, method, time frame, and frequency for the distribution of required information; person responsible for communicating the information; methods for updating the communications management plan; persons or groups who will receive the information; glossary of common terms; issues/concerns escalation procedures.

A change log is used to document changes that occur during a project. A lot of these changes can impact different stakeholder interests; thus, the change log is reviewed in this process.

Organization communication requirements, issue management procedures, change control procedures, and historical information are used.

Communication Methods

According to the needs of the project, the methods of communication identified for each stakeholder in the communications management plan are utilized during the manage stakeholder engagement process.

Interpersonal Skills

The project manager applies appropriate interpersonal skills or soft skills to manage stakeholder expectations by building trust and resolving conflict.

Management Skills

Management skills such as presentation skills, negotiation skills, writing skills, and public speaking skills used by the project manager can greatly influence how stakeholders feel about the project.

An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. It helps monitor who is responsible for resolving specific issues by a target date. There should be one owner assigned for each issue reported within the project.

Change Requests

Change requests can include a new change to the product or the project, corrective or preventive actions, and other items.

Project Management Plan Updates

The SMP portion of the PMP is updated as new stakeholders’ requirements are identified, existing requirements are changed, or as a result of addressing concerns and resolving issues of the stakeholders.

Project documents that may be updated include, but are not limited to, the following:

• Issue log: this will be updated as resolutions to the current issues are implemented and new issues are identified.

• Stakeholder register: this is updated as stakeholders’ statuses change, new stakeholders are identified, registered stakeholders are no longer involved or impacted by the project, and other factors.

Organizational Process Assets Updates

Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, and reasons for corrective actions chosen may be updated.

Control Stakeholder Engagement

The control stakeholder engagement is the process of evaluating and monitoring overall stakeholder relationships and ensuring stakeholders’ appropriate engagement in the project by adjusting plans and strategies as required. As the project progresses and its environment changes, this process will maintain or increase the efficiency and effectiveness of stakeholder engagement activities.

As per the PMBOK ® , the Control Stakeholder Engagement process has the following inputs, tools and techniques, and outputs:

Components of the PMP such as the human resource management plan, staffing management plan, communications management plan, change management plan, and others are used in controlling stakeholder engagement.

An issue is an obstacle that threatens project progress and can block the team from achieving its goals. An issue log is a written log document to record issues that require a solution. A modified issue log is developed as a result of identifying new issues and resolving current issues.

Work Performance Data

Work performance data such as resource utilization, deliverables status, schedule progress, percentage of work completed, number of defects, number of change requests, technical performance measures, costs incurred, quality updates, and other factors are used in this process.

Project Documents

Project documents such as issue logs, the stakeholder register, the project schedule, the change log, and others are used in this process.

Information Management Systems

An information management system is an automated system that can serve as a repository for information, a tool to assist with communication, and a system for tracking documents and deliverables. An information management system also supports the project from beginning to end by collecting and distributing information about cost, schedule, and performance for the stakeholders. Several reporting techniques such as spreadsheet analysis, table reporting, presentations, graphics for visual representations, and others may be consolidated from various systems and communicated to the stakeholders.

Judgment and expert opinions can be gathered from senior management, project team members, identified stakeholders, project managers from similar projects, subject matter experts, industry groups and consultants, other units within the organization, and other people to identify new stakeholders, reassess the current stakeholders, and figure out the level of involvement required from each stakeholder at various stages of the project.

Status review meetings with the team, sponsor, and other stakeholders will be beneficial for reviewing information about stakeholder engagement.

Work Performance Information

Work performance information such as deliverables status, change request implementation status, and forecasted estimates to completion are distributed through communication processes.

These are recommended corrective actions for bringing the imminent performance of the project as per the expectations in the PMP and recommended preventive actions for reducing the probability, and impact of future negative project performance will generate a lot of change requests.

Most of the components of the PMP may be updated to reflect changes in the stakeholder management strategy and the approach to effectively control stakeholder engagement in the project.

Project documents such as the issue log, the stakeholder register, and others may be updated.

Lessons learned from managing stakeholders, feedback from stakeholders, project records, causes of issues, reasons for corrective actions chosen, project reports, stakeholder notifications, and other items may be updated.

While the burden of disease is growing rampantly and disproportionately, the challenge to global health outreach efforts is to prioritize those illnesses, which require immediate attention. The global health equity sorts to prioritize on improving health care and achieving equity in health of people around the world. In this context, researchers from high income countries often study the existing diseases and/or emerging challenges in low income countries in order to gain expertise on the health care needs ( 20 ). In this regard, it is essential for overall program effectiveness that representatives of local communities, the stakeholders who will be most impacted by health outreach programs, be invited to provide their insights into which health needs are greatest. The encouragement of ShE and ShM often has a secondary benefit inasmuch as organization’s reputation is subsequently enhanced, which further facilitates organizational effectiveness. The very presence of stakeholders may foster an organizational environment, which encourages relevancy of program objectives to stakeholders’ expectations, a coupling, which in turn contributes to achievement of the project’s goals. Additionally, stakeholders can provide reality checks, which aid in the prioritizing of research objectives, in identifying potentially difficult political issues, and in providing the means to navigate around or to overcome challenges. The experience of stakeholders is thus invaluable for guiding research and achieving program objectives from their early stages in the laboratory to their final clinical application.

Although the process of partnering with stakeholders in clinical research settings is still in its nascent stages, it is anticipated that it will increasingly become accepted and implemented by project managers. In tandem with this process, greater efficiency and transparency will develop in working with stakeholders to meet targets ( 21 ). Part of the function of stakeholder analysis is to promote an understanding of stakeholders and to ensure that their expectations are being met. It is anticipated that project heads will increasingly encourage an awareness (ensuring transparency) of who will be affected by the project and who can contribute to making the project more successful.

Stakeholders have unique perspectives and often possess a number of capabilities which they have acquired from life experience. Program developers can derive the maximum benefit from stakeholders if the proper context is established for drawing out this experience. Alternatively, barriers to effective participation by stakeholders can occur if managers remain unaware of stakeholders’ skills, or if they believe that they do not have appropriate knowledge to contribute.

By increasing the acceptability of programs, stakeholders increase the likelihood of their success. Stakeholders play pivotal roles as healthcare advocates or healthcare ambassadors, partners, and/or agents of change. Although stakeholders differ considerably in their expertise and interests, their involvement is pivotal inasmuch as it can facilitate the successful completion of projects. Stakeholder participation can (a) improve relevance; (b) promote visibility and research transparency; (c) accelerate and translate the research findings to real-world challenges; (d) enhance greater project acceptance as confidence derived in the decisions made during the project’s milestone developments. Similarly, the project’s final outcome can only be considered successful when it is acknowledged by its key stakeholders.

Due to the broad range of ways in which stakeholders can influence program development, it is essential that their behavior be closely monitored, and modulated if necessary. One of the advantages of the described system of viewing the management of stakeholder engagement is that it documents many processes that have taken place. Future efforts to manage this type of engagement can therefore benefit from established experience.

In a nutshell, as Wheeler et al. ( 22 ) pointed out, “a truly stakeholder-responsive approach demands the acceptance of multiple stakeholders and requires that an organization develop a tolerance for ambiguity together with the sensitivities and capabilities needed to inspire trust with diverse and sometimes completing interests.”

A balanced assessment recognizes that certain caveats apply in the establishment of stakeholder engagement and management in clinical and research settings. These relate to the unique nature, demands, resources, and implementation issues which every organization has and how these demands can interact with the unique skills and abilities which stakeholders bring to it.

Many investigators lack clear or a basic understanding and/or training concerning the stakeholder framework as well as terminologies (Figure 2 ).

Figure 2. Project stakeholder management summary .

Often a reactive approach is favored over a proactive one for dealing with stakeholder issues is favored over a proactive one. As suggested by Greenwood, the “glorified depiction of stakeholder engagement gives way to the murky reality that engagement of stakeholders can mean many things to many people” ( 23 ). In this conceptualization, stakeholders may be viewed merely as actors with whom project managers form arms-length transactions rather making a tightly knitted partnership. This limited perspective may result in a failure to assess, understand the social, spiritual, and environmental needs of stakeholders.

Not every project can require or afford to have a full ShE or ShM system in place as outlined in this review. The main barrier here is that stakeholder involvement, and the fostering of attitudes that encourage this process, require a degree of organizational change (i.e., additional paperwork, more meetings, and more communication), which can be expensive. Hence, the benefits of managing a full program of stakeholder engagement, analysis, and management are only applicable to high impact projects. As Cennamo et al. ( 24 ) have noted a stakeholder-committed organization may still act out of self-interest. Thus, while localized programs may recognize and incorporate contributions from stakeholders and the larger community, these activities may continue to serve institutional objectives, which are narrowly focused or even possibly inimical to broader community interests. Additionally, stakeholder preferences are not absolute, but relative, and may also be evolving. Hence, the salience might change frequently across time. Another issue is that there is no generic “one size fits all” strategy for ShM and ShE, rather, the strategy and its execution depend very much on the local stakeholder landscape, as well as the problems that are being addressed. These include the stakeholder assets that are available and the opportunities that exist for their cultivation. Additionally, a barrier to effective participation and the subsequent consensus-building process is that the identified stakeholders may lack appropriate knowledge or skill sets, or believe, correctly or incorrectly, that they do not have appropriate knowledge to contribute and/or the investigators have the knowledge and experience to identify it. Stakeholders might have multiple perspectives and conflicting views, needs, and priorities. These may eventually result in identifying what they perceive to be the “best” or “appropriate” solution in any given situation, although the course of action might completely differ from that of investigators. This, in turn, results in potential “conflicts” and “trade-offs” in terms of project objectives. For example, the conflicting interest among the stakeholders with varied levels of power, importance, interest, and agenda must be managed efficiently. This poses a challenge to novice project managers to experienced investigators. These may potentially limit control mechanisms, and thus impede organizational performance. On the contrary, it is difficult to generate interest and involvement in projects, which are perceived to have little or immediate relevance. Finally and most importantly, while most of the ShE literature emphasizes the positive benefits of stakeholder engagement, it less frequently addresses the potential costs and risks with the adoption of a stakeholder perspective.

Above all, it is impossible to engage with stakeholders and to do stakeholder management in an authentic and effective way without dealing with the multiplicity of ethical issues that arise. These issues arise, first of all, because the stakeholders’ interests can conflict along key ethical dimensions. Therefore, engaging with them must be sensitive to the rights of the parties involved, as well as to the overall harms and benefits, which accrue from managerial action. Second, it is not always apparent when there may be conflicts of interests or hidden advantages or hidden disadvantages among key stakeholders and decision makers. Obviously, these conflicts must be disclosed, and many organizations have specific procedures for handling such conflicts. However, given the nature of the decisions that are to be made, managers must be willing to accept that effective stakeholder management places them squarely in the realm of ethical decision making.

It is not always possible to anticipate all of the ethical issues and conflicts, which may develop in such a multi-stakeholder environment. Therefore, the traditional method of assigning responsibility for solving these problems to an ethics committee does not always work. Clinical project managers must be willing to make choices based on both good ethics (based on PMI’s code of ethics and professional conduct) and on the overall purpose and values of their institution that is best for all stakeholders ( 27 ). While some ethical issues can be anticipated at the start of the project, all should be subjected to discussion among the project stakeholders to find the best possible course of action.

Assuming that the challenges reviewed above can be overcome, additional “higher order” issues will emerge. These will consist of how to best promote the operational adaptability, viability, and implementation of the changes in an acceptable timeframe. Project managers will need to ask if the benefits of managing a full stakeholder analysis are really greater than the costs associated with it. Efforts will also need to be directed toward retrospective analysis, i.e., did real cases go badly because the stakeholder views were not sought out? The difficulty of these questions varies in different clinical settings but it is essential that they be resolved for maximum project effectiveness.

In summary, the concept of promoting stakeholder engagement and management is a relatively recent one in the clinical research arena; hence, there are many lessons to be learnt in the coming years. As this is an iterative process, although the current efforts from funding agencies such as PCORI are necessary but are insufficient to respond to the above challenges. All indications are that attempts to meet these challenges will nevertheless provide significant benefits for project management effectiveness.

From a clinical standpoint, stakeholder engagement and management is pivotal to the development and deployment of community-oriented national and global health initiatives. The ultimate purpose of such engagement is the efficient use of time, money, and resources thereby positively impact existing and/or emerging healthcare challenges.

For the purpose of our review, we have followed the guidelines of PMBOK ® ( 7 ), which provides a common vocabulary to guide the processes. In doing so, our review outlines a systematic model for planning, managing, and implementing stakeholder engagement based on PMBOK ® guidelines. Further, the application of the project management knowledge, skills, tools, and techniques can augment the chances of success, even in complex projects.

This review has drawn on the experience of stakeholder engagement in private organizations and government agencies and has argued that the process is equally viable in hospital program development and in clinical research. It has taken the view that the concept of stakeholder engagement and a proper stakeholder management framework is more than a useful adjunct to pursuing project or program goals and is actually pivotal for enhancing organizational success.

These guidelines have been broken down into a number of component parts. It emphasizes that the stakeholders should first be identified, that their interests and expectations should be understood, and that their level of power and influence should be understood as well. A plan for communicating with stakeholders has been outlined and techniques for encouraging their participation and management have been laid out.

Author Contributions

All authors intellectually contributed to the design, analysis, and interpretation of the results and to drafting the critical review of manuscript. All authors reviewed and approved the final version of the manuscript.

Conflict of Interest Statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Acknowledgments

The authors would like to sincerely thank Professor Philip Kotler, S. C. Johnson & Son Distinguished Professor of International Marketing, Kellogg School of Management, Northwestern University, USA for his time, advice, and his valuable comments on the earlier versions of our manuscript, which enormously improved the quality of the final manuscript. We are also grateful for the comments from the anonymous reviewers. We gratefully acknowledge the National Institutes of Health; National Institute of Mental Health; Duke Endowment; South Carolina Department of Health and Human Services. As of the end of 2012, the Duke Endowment had provided more than $7.25 million in support of the program. Additional funding has come from the South Carolina Department of Health and Human Services, the National Institute of Mental Health (NIMH), and the National Institutes of Health (NIH). NIMH and NIH awarded two grants (one in 2009 and one in 2012) totaling $3.04 million to support evaluation of project outcomes (on quality, economic impact, utilization, and sustainability). In addition to grant funding, user fees and third-party insurance cover some program-related costs; for example, beginning in 2013, BlueCross BlueShield of South Carolina began covering use of telemedicine in mental health. However, the funders had no involvement in study design, data collection, data analysis and interpretation, preparation of the manuscript, or in the decision to submit the manuscript for publication.

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Appendix: Examples of Stakeholder Engagement

Statewide telepsychiatry initiative.

In one of our landmark study by the author (MN), the South Carolina Department of Mental Health partnered with the University of South Carolina School of Medicine, Department of Health and Human Services and 18 predominantly rural hospitals from the South Carolina Hospital Association to establish the statewide telepsychiatry initiative. In this public-private-academic partnership, the psychiatrists were available via teleconference 16 h a day, 7 days a week, to assess and treat patients with mental health issues at hospital emergency departments.

The clinicians called the psychiatrist on duty whenever they have a patient who needed a mental health assessment and/or counseling and provide relevant medical records and details. Through a secure video link, the psychiatrists were able to assess the patient and makes recommendations about needed treatment and follow-up, including referrals to community-based resources.

The advantage of such program was that, it drastically reduced emergency department wait times, inpatient admissions, as well as costs; increased attendance at follow-up outpatient appointments; and generated higher level of satisfaction among patients and clinicians. Additional evidence includes post-implementation surveys that gauge the satisfaction of patients and clinicians with the program.

In such an innovative approach, the stakeholder (State Department of Mental Health, University of South Carolina, Department of Neuropsychiatry and Behavioral Science, Hospital, Physicians and Nurses from the South Carolina Hospital Association, and Patients) engagement proved to be feasible, necessary, and beneficial in clinical environment.

Outcome of the Initiatives – Did it Work?

The program has reduced emergency department (ED) wait times, inpatient admissions, and costs; increased attendance at follow-up outpatient appointments; and generated high levels of satisfaction among patients and clinicians.

Shorter ED Wait Times: From March 2009 through 2014, the average waiting time for patients with mental health problems at the 18 participating EDs fell by roughly 50%. Fewer hospitalizations: during the same timeframe, 11% of ED patients assessed by a psychiatrist were hospitalized, half of the 22% admission rate among similarly cared-for patients in South Carolina EDs not offering this program.

Health care utilization: Telepsychiatry consultations resulted in an estimated $1,400 less per mental health patient compared to patients seen in ED’s that did not have telepsychiatry due primarily to the reductions in hospital admissions.

Greater attendance at follow-up appointments: About 46% of patients served by the program attended an outpatient follow-up appointment within 30ădays of the initial ED visit, well above the 16% attendance rate among similar ED patients cared for in South Carolina hospitals not offering the program. Similarly, 54% of patients served by the program attended a follow-up appointment within 90ădays versus 20% among ED patients in hospitals not offering the program.

High satisfaction among patients and staff: More than 80% of patients served by the program reported being satisfied with the process and services received. In addition, 84% of ED physicians and staff believe that the program has improved patient care; 91% report being satisfied with program-related procedures; and 84% express satisfaction with the technology used.

How We Did It: Planning and Development Process Key Steps Included the Following:

Decision to focus on telepsychiatry : The increasing popularity of telemedicine and its potential to bring services to underserved geographic areas made telepsychiatry a logical initial target for these discussions. After reviewing the use of telemedicine in South Carolina and other States, the partners collectively decided to create and implement a telepsychiatry program in hospital EDs.

Securing of funding for demonstration project : In 2007, program leaders contacted the Duke Endowment (a non-profit foundation that supports innovative health care programs) for funding a demonstration project. In 2008, the Duke Endowment agreed to provide a $3.7 million, 3-year grant for this purpose.

Project planning : Four hospitals agreed to participate in the demonstration project, which launched in March 2009. In advance of this date, the partners and participating hospitals worked together to hire and train six psychiatrists, install and test the video equipment in EDs, and set up an EMR system linking the psychiatrists with the EDs.

Program expansion : After the demonstration project went smoothly, program leaders decided in June 2009 to expand the program to three additional sites and have continued to add more sites gradually since that time. From March 2009 through August 2014, more than 20,000 telepsychiatry ED consults have taken place. As of August 2014, 20 hospitals participate, with plans to add 6 more in 2014.

Standardization of training : As the initiative expanded, program leaders standardized the training process for psychiatrists and ED staff, as outlined below:

Psychiatrist training : Participating psychiatrists complete 6ăh of clinical training by viewing videos prepared by University of South Carolina School of Medicine faculty. Supplemented with handouts, the videos cover child and adolescent psychiatry, adult psychiatry, geriatric psychiatry, addiction psychiatry, risk assessment, and legal issues. Newly hired psychiatrists also undergo peer review every 2ăweeks during their first 3ămonths of employment. In addition, during this initial 3-month period, the supervising psychiatrist meets with other hospital physicians to review and discuss consultations performed by newly hired psychiatrists.

ED staff training : ED staffs in participating hospitals watch a video that explains the videoconferencing system and reviews the goals of the program and the training and credentials of the participating psychiatrists. A member of the project leadership team visits each participating ED to discuss questions or concerns that staff might have about the program.

Ongoing meetings to resolve problems, plan expansion : Representatives of the partnering organizations and the participating hospitals meet on a quarterly basis to share program-related experiences, resolve any issues or problems that arise, and discuss and plan for expansion to other EDs. Typically, hospital administrators, providers, researchers, and information technology staff come to these meetings; representatives of non-participating hospitals are also welcome to attend to learn more about the program.

Resources Used and Skills Needed

Staffing : Six full-time psychiatrists and one part-time psychiatrist staff the program, under the supervision of a lead psychiatrist. The program includes several stakeholders namely a director, coordinator, fiscal technician, programmer, and two information resource consultants (subject matter experts; SMEs). Faculty and staff members from the University of South Carolina and Emory University, staff members from the Department of Mental Health and from the South Carolina Office of Research and Statistics also provide support to the program.

Costs : Hard data on the program’s total annual cost are not available. Major program expenses consist of staff salaries and the upfront and ongoing expenses associated with the videoconferencing and EMR technologies.

Keywords: PCORI, PMBOK, PMI, clinical research, code of ethics, professional conduct, project stakeholder management

Citation: Pandi-Perumal SR, Akhter S, Zizi F, Jean-Louis G, Ramasubramanian C, Edward Freeman R and Narasimhan M (2015) Project stakeholder management in the clinical research environment: how to do it right. Front. Psychiatry 6:71. doi: 10.3389/fpsyt.2015.00071

Received: 14 December 2014; Accepted: 27 April 2015; Published: 18 May 2015

Reviewed by:

Copyright: © 2015 Pandi-Perumal, Akhter, Zizi, Jean-Louis, Ramasubramanian, Edward Freeman and Narasimhan. 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) or licensor 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: Seithikurippu R. Pandi-Perumal, Department of Population Health, Division of Health and Behavior, New York University Medical Center, Center for Healthful Behavior Change (CHBC), Clinical and Translational Research Institute, 227 East 30th Street (between 2nd and 3rd Avenue), Floor # 6 – 632E, New York, NY 10016, USA, pandiperumal2015@gmail.com

Disclaimer: 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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What Does a Clinical Project Manger Do? Roles & Responsibilities

Clinical Project Managers (CPM) play a crucial role in advancing the progress of a clinical trial. The significance of CPMs lies in their ability to navigate complex clinical trials, ensuring precision, compliance, and efficiency.

As stewards of the entire research lifecycle, from planning to execution, Clinical Project Managers wield strategic thinking, leadership insight, and a deep understanding of regulatory landscapes.

In a world where the pursuit of groundbreaking therapies intensifies, the demand for skilled managers is reaching new heights, with organizations recognizing their pivotal role in trial success. 

This blog explores the pivotal responsibilities of clinical project managers and sheds light on why their expertise is becoming increasingly coveted, underscoring the crucial role they play in shaping the future of healthcare.

Table of Contents:

What is a Clinical Project Manager?

What does a clinical project manager do, skills required to become a clinical project manager.

• Essential Certifications or Degrees Required to become a Clinical Project Manager

How to Become a Clinical Project Manager?

Salary and job outlook for a clinical project manager.

A Clinical Project Manager (CPM) is an experienced expert in clinical research and healthcare management who is responsible for managing and coordinating the different aspects of clinical trials.

This multifaceted role encompasses strategic planning, execution, and monitoring of clinical research projects to ensure they adhere to regulatory standards, timelines, and budgets.

Clinical Project Manager acts as a connecting point between research teams, sponsors, regulatory authorities, and other stakeholders, facilitating effective communication and collaboration. 

Clinical Project Manager responsibilities include protocol development, risk management , team leadership, and navigating the complexities of regulatory compliance. By leveraging their expertise in project management, scientific understanding, and regulatory knowledge, they contribute significantly to successful clinical trials, ultimately advancing medical knowledge and bringing novel treatments to needy patients.

A Clinical Project Manager (CPM) is a pivotal figure in clinical trials, overseeing the intricate processes that lead to the successful execution of healthcare research. Their role encompasses many responsibilities, blending scientific expertise with project management skills to ensure the seamless progression of clinical trials.

Other key roles and responsibilities of a Clinical Project Manager:

• Strategic Planning: Develop comprehensive plans for the initiation, execution, and completion of clinical trials, aligning them with project goals and timelines
• Protocol Development: Contribute to the creation and refinement of study protocols, outlining the methodology, objectives, and criteria for participant selection
• Site Selection: Identify and evaluate suitable clinical trial sites, considering factors such as patient demographics, facilities, and regulatory compliance
• Regulatory Compliance: Navigate and ensure adherence to the complex web of regulatory requirements, obtaining necessary approvals and permissions for the clinical trial
• Budget Oversight: Manage the financial aspects of the clinical trial, ensuring adherence to the allocated budget and making informed decisions to optimize resource utilization
• Data Integrity: Oversee data collection and management processes, emphasizing the importance of data accuracy, completeness, and compliance with regulatory standards
• Problem Resolution: Address challenges and obstacles that may arise during the trial, making decisions that safeguard patient safety and ensure the integrity of the study
• Quality Assurance: Maintain a focus on the overall quality of the clinical trial, implementing measures to uphold ethical standards, patient welfare, and the reliability of research outcomes

Becoming a successful clinical project manager requires a diverse set of skills that combines scientific knowledge, project management proficiency, and effective communication. Below are some of the key skills that a clinical project manager is required to excel in the role:

1. Project Management Skills

• Planning and Organization: Ability to develop and execute comprehensive project plans, ensuring all aspects of the clinical trial are well-coordinated
• Time Management: Efficiently allocate resources, manage timelines, and prioritize tasks to meet project milestones
• Risk Management: Identify potential risks and proactively implement strategies to mitigate them, ensuring smooth project progression

2. Scientific Understanding Skills

• Clinical Research Knowledge: Familiarity with the principles and processes of clinical research, including study design, protocols, and ethical considerations
• Medical Terminology: Ability to understand and interpret medical and scientific terminology crucial for effective communication with research teams and stakeholders

3. Communication Skills

• Interpersonal Communication: Build strong professional relationships with diverse stakeholders , including research teams, sponsors, regulatory authorities, and site personnel
• Presentation Skills: Effectively convey complex information clearly and concisely, verbally and in written form

4. Leadership and Team Management Skills

• Team Building: Foster collaboration and cohesion within cross-functional teams, inspiring motivation and commitment to project goals
• Decision-Making: Make informed decisions promptly, especially in high-pressure situations, to address challenges and keep the project on track

5. Regulatory Knowledge and Skills

• Regulatory Compliance: Stay updated on and ensure adherence to relevant regulations and guidelines governing clinical trials in different regions
• Ethical Considerations: Understand and navigate the ethical considerations in clinical research, prioritizing patient safety and welfare

6. Problem-Solving Skills

• Critical Thinking: Analyze complex situations, identify root causes of issues, and develop effective solutions to keep the project moving forward

7. Financial Acumen

• Budget Management: Proficiency in managing project budgets, optimizing resource allocation, and ensuring financial accountability throughout the trial

8. Adaptability Skills

• Flexibility: Navigate unforeseen challenges and changes in project scope with adaptability, adjusting strategies and plans as needed
• Learning Agility: Stay abreast of advancements in clinical research, project management methodologies, and regulatory requirements

Essential Certifications or Degrees Required to Become a Clinical Project Manager

Becoming a Clinical Project Manager requires a combination of education, relevant degrees, and professional certifications. The specific requirements may vary based on the employer, industry sector, and the clinical trials complexity.

Here are some essential certifications and degrees that can enhance the qualifications of individuals aspiring to become Clinical Project Managers:

1. Educational Background

• Bachelor’s Degree: A bachelor’s degree in an appropriate field such as life sciences, healthcare, nursing, pharmacy, or a related discipline is frequently the minimum educational requirement
• Advanced Degrees: While not always mandatory, having a master’s degree (e.g., Master of Public Health, Master of Science in Clinical Research) or a Ph.D. can be advantageous, especially for more senior or specialized roles

2. Project Management Professional (PMP) Certification

The PMP certification is offered by the Project Management Institute (PMI), is widely recognized, and demonstrates proficiency in project management principles. It is valuable for Clinical Project Managers as they oversee complex clinical trials.

Achieve global recognition with the PMP certification from Invensis Learning. Benefit from expert trainers, flexible learning options, and success guarantees to propel your career to new heights. Enroll now to access exclusive discounts and become a certified leader in project management.

3. Certified Clinical Research Professional (CCRP) Certification

The Certified Clinical Research Professional (CCRP) certification is a professional designation offered by the Society of Clinical Research Associates (SoCRA). It is a worldwide recognized credential that demonstrates an individual’s skills and understanding of the principles and practices of clinical research.

4. Project Management Fundamentals (PMF) Certification

The Project Management Fundamentals (PMF) Certification is an entry-level credential offered by the Association for Project Management (APM) that validates an individual’s understanding of the fundamental principles and practices of project management. It is designed for those new to the field or wanting to formalize their project management knowledge.

5. Certified Clinical Project Manager (CCPM) Certification

The Certified Clinical Project Manager (CCPM) certification is a professional designation offered by various organizations that demonstrates an individual’s expertise in managing clinical trials and research projects. It validates their ability to effectively plan, execute, monitor, and evaluate clinical research studies, ensuring adherence to regulatory and ethical guidelines.

Becoming a Clinical Project Manager involves a strategic combination of education, experience, and professional development. Here’s a step-by-step guide on how to embark on a career as a Clinical Project Manager:

1. Get a Bachelor’s and a Master’s Degree

Embark on your journey by earning a bachelor’s degree in a relevant field, such as life sciences or healthcare. This foundational step equips you with essential knowledge for a career in clinical research.

To enhance your qualifications further, pursue a master’s degree, opting for specialized programs like a Master’s in Public Health (MPH) or a Master’s in Clinical Research.

2. Opt for an Entry-level Clinical Job

Kickstart your career with an entry-level position in clinical research, such as a Clinical Research Assistant or Coordinator. These roles expose you to the day-to-day operations of clinical trials, providing valuable insights into research protocols, data management, and regulatory compliance.

3. Gain Clinical Research Experience

Actively seek hands-on experience in clinical research, engaging in tasks like patient recruitment and study coordination. Develop a strong understanding of Good Clinical Practice (GCP) guidelines and ethical considerations. This practical experience lays the groundwork for a well-rounded skill set and prepares you for more advanced roles.

4. Build a Strong Resume

Create an effective resume that highlights your educational background, relevant coursework, and practical experience. Emphasize key skills such as attention to detail, data management, and knowledge of regulatory standards. Include certifications, like GCP, to underscore your commitment to maintaining high-quality standards in clinical research.

5. Find a Position as a Clinical Project Manager

Progress in your career by applying for roles with increasing responsibilities, focusing on project management within clinical trials. Leverage your educational background, practical experience, and certifications to showcase readiness for a Clinical Project Manager role. Highlight your ability to lead teams, manage timelines, and strictly adhere to regulatory standards.

Before switching any career, individuals should know two main things: one is salary growth and the other one is job opportunities. The salary and job outlook for a Clinical Project Manager (CPM) can vary based on factors such as experience, education, location, and the specific industry within healthcare or clinical research. It’s essential to note that salary trends and job outlook may evolve over time.

Salary of a Clinical Project Manager

The salary prospects for a clinical project manager are generally quite positive. They play a crucial role in the healthcare industry, overseeing the planning, execution, and monitoring of clinical trials and research projects.

Their expertise in project management, clinical research methodology, and regulatory compliance ensures the successful completion of these studies, leading to the development of new drugs, treatments, and medical devices.

Experience is a significant factor in determining salary. The salary ranges for clinical project managers are as follows:

Clinical project managers have the potential to experience significant salary growth throughout their careers. With increasing experience, specialized skills, and advanced certifications, clinical project managers can advance into senior-level positions with higher earning potential.

Additionally, the demand for clinical project managers is expected to grow faster than average in the coming years, further contributing to positive salary prospects.

Job Outlook of a Clinical Project Manager

The job outlook for clinical project managers is exceptionally promising, driven by the increasing demand for clinical trials, the growing complexity of research projects, and the expanding healthcare needs of an aging population.

As per the US Bureau of Labor Statistics (BLS) , employment of medical and health services managers, which includes clinical project managers, will expand by 32% from 2020 to 2030, much faster than the average for all professions. This growth is related to the aging population and the increasing demand for healthcare services.

Here are some specific factors that contribute to the positive job outlook for clinical project managers:

• Increasing demand for clinical trials
• Growing complexity of clinical trials
• The aging population and rising healthcare needs
• Expansion of medical group practices

Clinical project managers can pursue diverse career paths and advance into senior-level positions with increasing responsibilities and higher compensation.

Some potential career trajectories include:

• Clinical Research Associate (CRA)
• Clinical Research Coordinator
• Clinical Research Manager
• Director of Clinical Research
• Clinical Research Program Manager
• Clinical Research Portfolio Manager
• Clinical Project Manager Specialist
• Clinical Project Manager Lead
• Global Clinical Project Manager
• Senior Clinical Project Manager
• Executive Clinical Project Manager

A clinical project manager plays a pivotal role in the healthcare industry, ensuring the successful execution of clinical trials and research projects. Their expertise in project management, clinical research methodology, and regulatory compliance is crucial for bringing new drugs, devices, and therapies to patients, improving healthcare outcomes, and advancing medical knowledge.

If you are passionate about healthcare, have strong organizational skills, and possess a keen eye for detail, a career as a clinical project manager could be a rewarding and fulfilling path. With the right education, experience, and certifications, you can significantly impact the future of healthcare by overseeing the development of life-saving treatments and technologies.

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Clinical Research Project Plan

Needless to say, medicine today is quite different from the past. It has also come from a long history. When we say ancient medicine, the first things that would come to our minds are the times where people still believed that illnesses served as punishments by the Gods due to the bad things that people did. Our ancestors from a particular era also thought that sicknesses such as diarrhea were perfectly normal and are just natural occurence. Thus, such occurrences didn’t require  medicine  or other medical interference to solve. However, that is just part of a long history of medicine. Along with the advancement of technology, smart people have come up with a better approach to deal with these illnesses, and clinical research is just one of the healthcare studies that we are practicing to better our health.

Clinical research, just like medical research , is a broad category to discuss in just one article, but today we are going to tackle one of the sections that make this type of research – Clinical Research Project Plan.

What is Clinical Research?

Generally speaking, clinical research is the study of human health. It aims to secure the safety and effectiveness of health-related tools and methods such as medications, medical devices, and treatment regimens. Through these studies, medical professionals can ensure the efficacy of the products that they use for diagnosis, treatment, and prevention of deceases that people may endure. This science healthcare branch includes the studies or clinical trials conducted under the following categories: mental health, social health, physical health.

Clinical researchers from university medical centers and affiliated research study sites are usually the ones who are executing this type of researches as part of their Ph.D. application or typical undergraduate research. These areas have access to more resources for medical participants. They have high standards in terms of following the proper ethical conduct of medical research, thus, making these grounds for effective clinical studies.

Simply put, the clinical research plan contains an overview of the clinical research that you are proposing. You will have to submit this document along with the other sections of your research proposal . This document is one of the things that your research stakeholders will look at when considering the approval of your proposed plan. To create a good research plan, make sure that your project answers the following questions.

What are the goals of the research? Why are these goals important?

Providing research goals is an essential part of conducting a study. In this part, you should state the specific objectives of your research. We recommend you to include a whole page document for this section.

What are the things that people, such as the researchers, concerning this project have done so far?

Is there existing research that needs a follow-up study? Is there a system that the hospital is following? You will have to specify all the current activities that the field is currently practicing and other existing factors in connection to your proposed research.

How are you going to achieve the goals of your research?

Aside from the goals, your research plan should include the steps that you are going to take to achieve these goals. To do that, you will have to include elements such as strategy. In this part, you will assure the research stakeholders that you will attain the goals of your study.

11+ Clinical Research Project Plan Examples & Templates

Now that you have a better understanding of the clinical research project plan take a look at these examples and templates. You can use these downloadable documents as a reference or guide to create a layout for your student research.

1. Research Plan Template for Pragmatic Clinical Studies

Size: 31 KB

2. Sample Research Plan Proposal

Size: 191 KB

3. Example of a Well-Written Clinical Research Plan Proposal

Size: 102 KB

4. Research Plan Proposal Sample

Size: 106 KB

5. Medical Student Resesarch Plan Proposal

Size: 232 KB

6. Template for essential information to be provided for proposals including clinical trials / studies / investigations

Size: 134 KB

7. Research Plan for Clinical Research Study With No External Sponsor

Size: 26 KB

8. Writing a Research Plan

Size: 131 KB

9. Biomedical Research Protocol

Size: 154 KB

10. Research Plan Proposal Form

11. Research Plan Proposal Template

Size: 14 KB

12. Health Sector Workpace Violence Research Plan

Size: 233 KB

Tips on Writing a Research Plan

Come up with a useful subject.

When writing a research plan, you should remember that your goal is for the stakeholders to approve your project, and selecting your research subject will play a significant role in the approval that you want. Choose a topic that will compel and impress your leaders. You can do some research and list the latest trends that you think are worth it to tackle. However, the best way to convince your leaders is to come up with a topic that you feel is important. In that way, it will be easier for you to persuade the importance of your work.

Make Your Plan Brief

Choosing a compelling topic is just the beginning. Think of a TV drama with a promising trailer or hit pilot episode but had to cancel after the first season due to the gradually declining ratings. What could have possibly happened? Aside from the story is not clicking, most of the time, this scenario occurs when the maker is stretching the storyline to the point that it becomes dragging and boring. You don’t want that to happen on your project plan. Make your research plan brief and concise. To do it, you have to refine your research plan in a way that you only include essential items.

Be Realistic

We know that coming up with an interesting topic is a great idea in creating a research plan. However, you should also remember that you are proposing a research plan to create a solution. Therefore, you have to ensure that your plan’s objective is realistic. In this way, you can ensure that there will be no holes in your plan, and it will also be easy for you to defend and answer the questions of the stakeholders, especially during the research project proposal period.

Include a Preliminary Data

Do your research! When proposing a research plan, you have to make specific preparations. One of them is researching the existing research made for the topic that you choose. As mentioned earlier, to create a good research plan, you have to ask yourself for things concerning your project that has done so far. Look for the data and results generated by prior research, demonstration, development such as structured and literature interviews. You will, then, include this data to your research plan.

Science has indeed enlightened us in so many ways. One of the best contributions that it has given to humanity is the advancement of clinical matters. Our great thinkers uncover better methods to deal with humans’ health. Through clinical research, we benefit from inventions that we have today with lesser adversaries. Better approaches to diagnose, treat, and prevent diseases are within reach. In this article, we have discussed one of the essential components of clinical research, which is the clinical research plan.

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Develop a project timeline for a middle school science fair.

Project Plan Template for Clinical Research

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• Organize and track project tasks
• Break down projects into manageable goals and tasks
• Communicate progress to all stakeholders involved

Benefits of a Clinical Research Project Plan Template

• Develop an overall timeline for the project
• Specify milestones and corresponding deadlines
• Recognize any special considerations or constraints related to the project
• Identify resources required for the project

Main Elements of a Project Plan Template for Clinical Research

• Who will be responsible for each phase of the project?
• What resources will be needed in each phase?
• When will each phase start and end?
• Who will be responsible for budgeting and controlling costs?
• How will data collection be performed?

How to Use a Clinical Research Project Plan Template

1. identify the objective., 2. outline scope and methodology., 3. develop criteria for success., 4. assign resources and roles., 5. develop risk management strategies., 6. monitor progress., related project plan templates.

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10+ SAMPLE Clinical Research Project Plan in PDF | MS Word

Clinical Research Project Plan | MS Word

10+ sample clinical research project plan, what is a clinical research project plan, different types of clinical research project plans, basic components of a clinical research project plan , how to write a clinical research project plan, how to become a good clinical project manager, what are the different types of clinical trials, what are some examples of clinical research project plans, how to manage and monitor a clinical research project plan.

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1. clinical research project plan & evaluation, 2. clinical research project development plan, 3. clinical research project improvement plan, 4. covid-19 clinical studies research project plan, step 1: follow the general advice , step 2: include the introduction, background, and hypothesis, step 3: explain the study design or approach, step 4: develop a summary , step 5: set a research timeline , step 6: proofread and prepare the overall plan, share this post on your network, file formats, word templates, google docs templates, excel templates, powerpoint templates, google sheets templates, google slides templates, pdf templates, publisher templates, psd templates, indesign templates, illustrator templates, pages templates, keynote templates, numbers templates, outlook templates, you may also like these articles, 5+ sample investment company business plan in pdf.

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Improving Communication in Clinical Research

By: Anatoly Gorkun, MD, PhD, Chartered MCIPD             Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

Introduction

Communication is a key tool for clinical researchers, yet problems due to inactive communication are common. It is important to monitor possible ineffective communication in order to develop effective solutions to proactively prevent the negative consequences of ineffective communication.

Some time ago, the author received feedback from two clinical trial managers (CTM) on the same clinical research associate (CRA) at the same time. One clinical trial manager said:

(CTM’s Name) “is perfectly performing as expected from an experienced CRA. Her time has been allocated to manage a few difficult sites. Due to her learning agility and deep experience, the situation is improving now. She is a very good team player.”

The other clinical trial manager told the author:

“I know this CRA is new to the company and is still learning; however, with the upcoming data cleaning, I need your help.

I would suggest she has a co-monitoring visit with someone who is experienced. She needs to understand that this reconciliation is not just making a match between source data vs. case report form but also questioning what is being reported and identifying gaps, and being able to address issues with the site staff.

I would appreciate your feedback and actions.”

Both studies were relatively similar, and in this specific example, the problem appeared to be the communication between the CRA and CTM.

The Importance of Communication in Clinical Research

There are various definitions of communication, including:.

“The imparting or exchanging of information by speaking, writing, or using some other medium.” ( oxforddictionaries.com )

“Two-way process of reaching mutual understanding, in which participants not only exchange (encode-decode) information, news, ideas, and feelings but also create and share meaning.” (businessdictionary.com).

The second definition is broader and reflects the nature of communication more accurately.

Poor communication in clinical research has many negative effects (Table 1) including stress, possible conflicts between clinical research professionals, and a breakdown in relationships. Other negative effects of poor communication are unmet expectations (ineffectiveness), wasted time because work is inefficient and must be re-done, non-compliance, possible harm to subjects, and possible invalidation of data.

As an example: an in-house CRA approached the line manager and said, “I’ve done what the project team wanted, but when I finished the task they said it was not what they expected.” The line manager asked if the CRA had checked with the project team before starting the task to clarify what they wanted. She said, “No, because the task seemed very clear.”

Communication that is free of assumptions is one of the characteristics of ideal communication (Table 2). It is important to listen, ask questions to ensure understanding of the task, agree to what needs to be done, and confirm the agreement. Communication is a two-way process that requires mutual understanding.

Successful Communication Methods

The most suitable method of communication depends upon the situation and to some extent, the receiver’s preferences. For urgent situations, a telephone call is best, followed by an email to summarize the call. The communicator should not bombard the person with emails, because he/she does not know whether the person is receiving and reading the emails. In some situations, more than one communication method is appropriate, such as emailing instructions and then following up with a telephone call.

Sometimes it happens that the site monitor and the in-house CRA as well as the project assistant may ask the research nurse at the site the same question. This may not be the most efficient approach. Communication should be streamlined in order to prevent it from being chaotic.

The following email communication is between a clinical trial manager (CTM) and a CRA on an urgent issue that required immediate attention. A delay in resolving the issue might affect deliverables and the company’s image.

• CTM → CRA, February 21: Check if all Adverse Events were entered into eCRF. Urgent, due in 2 days. Table attached.
• CTM → CRA, February 24: “A kind reminder, please.”
• CTM → CRA, February 24: “Please send me your answers today.”
• CTM → CRA, February 28: “I need your answers, please.”
• CTM → CRA, March 01: “Client requested us to provide the answer. Please complete this task.”
• CTM → CRA, March 06: “I need your answers URGENTLY please.”
• CTM → CRA, March 06: “Please do it tomorrow and let me know.”
• CRA → CTM, March 06: “I would do, but I don’t know what to check.”
• CTM → CRA, March 06: “The table is attached.”
• CTM → CRA, March 08: “Any news from the sites?”
• CRA → CTM, March 08: “Hopefully tomorrow.”

The clinical trial manager sent the first email to the CRA on February 21st and did not receive a reply from the CRA until March 6 th , nearly two weeks later. When the CRA responded that she did not know what to check, the CTM simply forwarded the same attachment. The CTM should have picked up the telephone and talked to the CRA.

Ideal communication is transparent. Transparency is:

“the perceived quality of intentionally shared information from a sender”

(Schnackenberg AK, Tomlinson EC. (March 2014). “Organizational transparency: a new perspective on managing trust in organization-stakeholder relationships,” Journal of Management . 10.1177/0149206314525202).

Transparency makes it easy for others to understand what actions have been completed and which actions need to be taken. It implies openness and accountability.

In another case, a project manager sent the following message to a line manager:

“As you know [name of CRA2] replaced [name of CRA1] at the end of March.

Unfortunately, by that date, the site performance decreased with late queries and SDV (Source  Data Verification) backlog due to pending monitoring visits.

Until today both sites still have not been visited and the plan is not available. I appreciate if you guarantee to have both sites visited by the end of April.”

The line manager spoke to the CRA, who said that the visits had been scheduled a long time ago. The project manager had been on holiday. When the project manager came back, he did not speak with the CRA about the status of the visits but instead escalated the issue.

Considerations in using appropriate communication include:

• The purpose of the specific communication
• How communicating will benefit the situation
• Whether something different can be done
• Whether alternative communication is necessary, and if so, the best method to use.

In the example, considering these four questions would have enabled the project manager to realize that talking directly to the CRA was the appropriate communication method for this situation.

In this case, the CRA needed advice from the CTM:

CRA: “I need to complete a number of overdue study-specific learning items on my LMS (Learning Management System) but I don’t have time. I am so busy.”

 CTM: “Then, do it wisely.”

The advice was not clear. Communication must also be concise. It is necessary to be clear about the purpose/goal of the message, to stick to the point, and to be brief.

Ideal communication is timely. In determining the best time for the message, the communicator must consider whether to communicate now or later. In some cases, it is better to wait and to communicate one message with another. It may also be helpful to pre-prepare the receiver of the communication with a brief heads-up.

A CRA was having communication issues with two clinical research sites. At the same time, this CRA had to deliver a presentation at a departmental meeting and wanted feedback from the line manager. The line manager knew that the sites were struggling to work with this CRA because of his insufficient communication skills. The line manager decided to wait a couple of days to speak with the CRA about his presentation/communication skills and the issue with the sites at the same time, as that was a good chance to demonstrate the importance of expressing thoughts clearly and explicitly.

It is also important to acknowledge receipt of an email or other communication when we are not going to provide our answer immediately. For example:

“I’ve received your message. It will take me a week to collect the requested information. I’ll get back to you by …”

Ideal communication is diplomatic and constructive. It is okay to disagree with someone; however, communication should focus on a person’s opinion or approach and not insult the person. For example, instead of saying,

“I don’t agree with you …,” say something like, “May I suggest that we discuss more options …”

An in-house CRA sent the following email message to a research nurse:

“I sent you my request 2 weeks ago, and it’s complete silence from your side. I find it so frustrating because we need to close all queries by the end of this week.”

The research nurse said that she would not respond to requests like this. After coaching the in-house CRA on communication methods, there was a visible improvement noticed, and the relationship with the site improved.

It is always better to be constructive. Avoid being very direct or pushy, and suggest options instead of criticizing or expressing frustration.

Ideal communication must be culturally respectful since clinical research is conducted internationally. Culturally respectful communication helps to avoid misunderstanding, to establish rapport, to build better relationships, and to facilitate more efficient work. Even among English-speaking countries, words or phrases can have slightly different meanings. For example, in the United States, “I hear what you say” means that the communicator accepts the other person’s point of view. In the United Kingdom, it may rather mean “I am not keen on discussing it further as I am not in agreement with this.” Also, accepting country or region-specific accents should be a part of cultural respect.

Ideal communication is also fair.

The following communication happened between a site monitor and a line manager.

Site monitor to line manager:

“I’m very busy and working very hard, however, I do not get enough support from the in-house CRA.”

The monitor’s line manager to in-house CRA’s line manager:

“I think that the in-house CRA might provide better support to the site monitor. Could you please check on the issue with the CRA’s performance and fix it?”

It turned out that the in-house CRA was doing a good job; however, the problem was that the site monitor needed to provide an explanation regarding the backlog of work that was created and decided to blame the in-house CRA for lack of support. Communication should be fair and should not blame other people unfairly.

Ideal communication is open, honest, and logical.

The following examples highlight communication between a line manager and a direct report during two performance reviews and a 1:1 meeting.

Mid-year performance review meeting, Line Manager to a direct report:

“You are leading a very important project really well. It’s going to be a great year for you!”

Monthly one-to-one meetings throughout the year:

The project delivery was on time and good quality. Every month, the line manager confirmed that she was happy with all of the work and there was nothing to improve.

End-of-year performance review meeting, Line Manager to a direct report:

“You’ve been struggling to deliver the project and managing it below expectations.”

The end-of-year performance review feedback was not logical because the previous messages were all positive. Ideal communication should avoid misunderstanding, conflicts, and disappointment.

Ideal communication is well-structured and compelling. Communicators should try not to tell a long story that makes it difficult for the receiver to determine what the communicator needs. This is important in everyday life with everyone, including communication with senior leaders and clinical investigators, both of whom are usually very busy.

The “rhetorical kipper” from Gareth Bunn can be used to plan communication. Using this model, communication is designed from the “tail of the kipper” and delivered from the “head.” After presenting the topic, three ideas or points are presented, and then finally, the request is made or the main message is delivered. The author’s direct reports found it useful to apply the rhetorical kipper method. Proper communication should be positive, assertive, and inspirational.

Case Study on Different Feedback

The case study presented at the beginning of this article illustrated different feedback from two clinical trial managers on the same CRA. One clinical trials managers stated that:

[CRA’s Name] “is perfectly performing as expected from an experienced CRA.

She has been allocated to manage a few difficult sites. Due to her learning agility and deep experience, the situation is improving now. She is a very good team player.”

I would suggest that she has a co-monitoring visit with someone experienced. She needs to understand that this reconciliation is not just making a match between source data vs. case report form but also questioning what is being reported and identifying gaps, being able to address issues with the site staff. 

I would appreciate reviewing your feedback and actions.”

The reason for the different feedback was not different complexity of the studies but that the clinical trial manager was micro-managing the CRA. She had a different management style than the CRA was used to. The first clinical trial manager delegated the tasks and trusted the CRA to complete them. The second clinical trial manager required daily reports from the CRA, assuming that if there was no daily report, it meant that the job was not done. She also had negative experiences working with a previous CRA and assumed that the new CRA would act in the same way.

Thus, the second clinical trial manager’s style was based more on assumptions. After a root cause analysis of the situation, the CRA learned how to recognize different working styles and started working with the second CTM more efficiently.

Many skills are required for appropriate and effective communication (Table 3), including listening and observing, planning, and dealing with difficult situations dearly and empathetically. Methods of ensuring that communication is appropriate and effective include awareness of communication issues (Table 4). If we face a communication issue, we should not assume that it will disappear by itself. A root cause analysis should be done to determine the cause of the issue, and then a plan should be developed to manage the problem. The plan should include feedback to ensure that the other person understands and accepts the plan. Line managers can arrange for soft skills coaching and training for people who need to improve their communication skills. If nothing else works, such issues can be escalated.

In clinical research, it is important to monitor possible ineffective communication approaches and to proactively develop effective solutions to prevent negative consequences.

The Effects of Poor Communication in Clinical Research

• Possible conflicts and breakdowns in relationships
• Unmet expectations (ineffectiveness)
• Waste of time (inefficiency)
• Non-compliance
• Possible harm to subjects
• Possible invalidation of data

Ideal Communication

• Assumption-free
• Proper methods utilized
• Transparent
• Appropriate
• Clear and concise
• Diplomatic and constructive
• Culturally respectful
• Open, honest, and logical
• Well-structured and compelling
• Proper communication style

Communication Skills

• Listening and observing
• Nonverbal communication (body language, facial countenance)
• Negotiations
• Dealing with difficult situations
• Friendliness
• Flexibility (open-mind)
• Giving and receiving feedback

Communication Strategies to Prevent or Fix Issues

• Be aware of communication issues
• Observe and discover issues
• Do not assume that the issues disappear by themselves
• Perform root-cause analysis 
• Feedback, and how to ensure that it is understood and accepted
• Soft skills coaching
• Soft skills training
• Escalating (if nothing else works)

6 thoughts on “Improving Communication in Clinical Research”

Nice article.thanks

Be sure to communicate in the mindset of a team member, or stakeholder with the same goals and not as an outsider looking in with judgement.

This is a great inspiring article.

Nice article! Thanks for sharing this informative post. Keep posting!

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Project 5 in 5

Crowdsourcing 5 clinically relevant questions for 5 pragmatic trials

The FDA Oncology Center of Excellence (OCE) Project 5 in 5 is a crowdsourcing initiative to ultimately identify 5 clinically relevant questions that can be answered through use of pragmatic clinical trials, using FDA-approved oncology therapies, over the next 5 years.

The resulting ideas will be shared with government agencies, cooperative groups, and others who may be interested in implementing these pragmatic clinical trials. The OCE is serving as the convener but will not be involved in the implementation or conduct of the clinical trials themselves. This initiative is important to accelerate patient-centric clinical trial innovation.

The crowdsourcing initiative will run from May 5 through July 5, 2024. The OCE invites anyone interested to submit ideas.

Visit the Project 5 in 5 Crowdsourcing Web Page

Click the image below to hear about this crowdsourcing project from Richard Pazdur, MD , Director of the Oncology Center of Excellence!

Pragmatic Clinical Trials

Pragmatic clinical trials aim to streamline data collection and design by collecting only necessary information to answer the research question. The focus should be on efficacy, using a straightforward clinical benefit endpoint such as overall survival. Traditional prospective randomized controlled trials in oncology are typically associated with significant monitoring, assessments, tests, and clinical follow up visits that can be burdensome to trial participants, investigators, and trial sponsors.

Pragmatic clinical trials may incorporate design elements that are more reflective of routine clinical practice. Pragmatic trial elements take advantage of functional efficiencies such as fewer and broader eligibility criteria and flexibilities in trial delivery and outcome measurement. The degree of flexibility is tailored to the trial context, keeping the safety of patients and the integrity of trial data at the forefront. Studies conducted in the real-world setting can reduce the burden of trial participation, with the hope to facilitate more diverse trial populations, more rapid enrollment, and reduced attrition. Pragmatic trials may have the potential to result in evidence that is more broadly representative of the general population affected by the clinical question.

Project 5 in 5 FAQs

Q: Where can I get more information about pragmatic clinical trials?

A: Please visit the OCE's  Project Pragmatica .    Q: How will the FDA select the top 5 ideas for pragmatic clinical trials?

A: FDA hematologists, oncologists, and clinical experts will review and identify the most popular ideas from the external crowdsourcing that meet the outlined specifications.

Q: Will the FDA conduct these clinical trials?

A: No, the FDA’s Oncology Center of Excellence plans to provide these ideas for pragmatic clinical trials to the oncology community for discussion, and potentially involve the National Cancer Institute (NCI), NCI-supported clinical trials cooperative groups, advocacy organizations, pharmaceutical companies, and other potential funders to encourage qualified entities to carry out these trials.

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Clinical trials: A significant part of cancer care

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Editor's note: May is National Cancer Research Month.

By Mayo Clinic staff

A cancer diagnosis is an emotional experience. Learning that you have cancer can create feelings of hopelessness, fear and sadness. This is especially true if your cancer is advanced or available treatments are unable to stop or slow its growth.

"Often, when patients are diagnosed with cancer , they feel hopeless and scared. Clinical trials are one way patients can be proactive. They can make a choice in how their care is going to be," says Matthew Block, M.D., Ph.D. , a Mayo Clinic medical oncologist.

Cancer clinical trials help physician-scientists test new and better ways to control and treat cancer. During a clinical trial, participants receive specific interventions, and researchers determine if those interventions are safe and effective. Interventions studied in clinical trials might be new cancer drugs or new combinations of drugs, new medical procedures, new surgical techniques or devices, new ways to use existing treatments, and lifestyle or behavior changes.

Clinical trials provide access to potential treatments under investigation, giving options to people who otherwise may face limited choices. "Clinical trials open the door to a new hope that maybe we can fight their cancer back and give them a better quality of life," says Geoffrey Johnson, M.D., Ph.D. , a Mayo Clinic radiologist, nuclear medicine specialist and co-chair of the Mayo Clinic Comprehensive Cancer Center Experimental and Novel Therapeutics Disease Group.

You will receive cancer treatment if you participate in a clinical trial. "I think one common misperception about clinical trials is that if you enter a clinical trial, you may not get treatment (receive a placebo). And that's actually very much not true. Most clinical trials are looking at one treatment compared to another treatment," says Judy C. Boughey, M.D. , a Mayo Clinic surgical oncologist, chair of Breast and Melanoma Surgical Oncology at Mayo Clinic in Rochester, Minnesota, and chair of the Mayo Clinic Comprehensive Cancer Center Breast Cancer Disease Group.

"I think one common misperception about clinical trials is that if you enter a clinical trial, you may not get treatment (receive a placebo). And that's actually very much not true. Most clinical trials are looking at one treatment compared to another treatment." Judy C. Boughey, M.D.

Watch this video to hear the experiences of people who have participated in cancer clinical trials and to hear Drs. Block, Johnson and Boughey discuss the importance of clinical trials in cancer care:

Clinical trials are a significant part of cancer care at Mayo Clinic Comprehensive Cancer Center. Cancer care teams work together across specialties to make sure the right clinical trials are available to serve the needs of people with cancer who come to Mayo Clinic.

"We are very particular in how we select the clinical trials that we have available for patients," says Dr. Boughey. "We want to have the best trials available for our patients. Some of the clinical trials are evaluating drugs — we are so excited about those drugs, but we can't prescribe those drugs for patients without having that trial. And so we will actually fight to try to get that trial open here to have it available as an opportunity for our patients."

If you choose to participate in a clinical trial, you will continue to receive cancer care. "For most patients that we evaluate, there's always the standard of care treatment option for those patients. And then, in many situations, there's also a clinical trial that the patient can participate in," says Dr. Boughey.

People who participate in clinical trials help make new and better cancer care available for future patients. The treatments available for cancer patients today exist because of the clinical trial participants of yesterday. "We couldn't advance medicine if it wasn't for people volunteering for trials. And the promise from our side is to say we're not going to put patients on trials or offer trials for them to consider unless we think there's a good chance that they'll get a benefit or that society at large will get a benefit," says Dr. Johnson.

"We couldn't advance medicine if it wasn't for people volunteering for trials. And the promise from our side is to say we're not going to put patients on trials or offer trials for them to consider unless we think there's a good chance that they'll get a benefit or that society at large will get a benefit." Geoffrey Johnson, M.D., Ph.D.

Participating in a clinical trial may give you access to cutting-edge treatment, improve your quality of life and extend your time with loved ones.

"It's definitely worth reaching out to your healthcare provider and asking, 'What clinical trials could I be a potential candidate for?'" says Dr. Boughey. "And remember, you can ask this of your surgical oncologist, your medical oncologist, your radiation oncologist, or any of the physicians you're seeing because there are trials in all disciplines. There are also ongoing trials that require the collection of tissue or the donation of blood. They can also be important in trying to help future generations as we continue to work to end cancer."

Participating in a clinical trial is an important decision with potential risks and benefits. Explore these FAQ about cancer clinical trials, and ask your care team if a clinical trial might be right for you.

Learn more about cancer clinical trials and find a clinical trial at Mayo Clinic.

Join the Cancer Support Group on Mayo Clinic Connect , an online community moderated by Mayo Clinic for patients and caregivers.

Read these articles about people who have participated in clinical trials at Mayo Clinic:

• A silent tumor, precancerous polyps and the power of genetic screening
• Mayo Clinic’s DNA study reveals BRCA1 mutations in 3 sisters, prompts life-changing decisions

Read more articles about Mayo Clinic cancer research made possible by people participating in clinical trials.

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Trials to watch: Four ALS drugs to keep an eye on

There are a total of 12 candidates in mid to late-stage trials for ALS poised to enter the market in the next five years.

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It has been a turbulent few weeks for patients with amyotrophic lateral sclerosis (ALS) after Amylyx Pharmaceuticals pulled its lead drug Relyvrio from the market after a Phase III trial did not meet its primary endpoint.

The drug was pegged to be revolutionary for patients as it was said to slow disease progression, however Phase III data showed no difference between the candidate and placebo.

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Despite this setback, chief research officer at the Muscular Dystrophy Association, Dr Sharon Hesterlee, says that there are plenty of novel candidates in the pipeline. “The good news is the pipeline is healthy for ALS, which is important, especially given what has happened with Amylyx’s drug which was disappointing for everyone,” Hesterlee explains.

There are only six FDA approved drugs for ALS – just one of which, riluzole, is a disease modifying therapy, leaving a great need for more treatment options.

Momna Ali, neurology analyst for GlobalData says: “There are 12 assets in their mid-late-stage development (Phase II–III) which are poised to enter the market within the next five years. With numerous pipeline agents that have a diverse mechanism of action under investigation, key opinion leaders interviewed by GlobalData in January 2024 anticipate the treatment landscape to evolve significantly within the next decade.”

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HEALEY Platform trial investigates Calico and AbbVie drug

The HEALEY ALS Platform Trial (NCT04297683) is a perpetual multi-centre, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen F is a Phase II/III trial (NCT05740813) which will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, in patients with ALS. ABBV-CLS-7262 has been developed in a partnership between Calico Life Sciences and AbbVie .

Regimen F plans to enrol 300 patients with a primary completion date of September 2024.

ABBV-CLS-7262 is an oral candidate which acts by targeting eukaryotic translation initiation factor 2 subunit beta (EIF2B).

The primary endpoint is change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score at 24 weeks.

Secondary endpoints include muscle strength, respiratory function, and disease progression biomarker at 24 weeks.

“In the last couple of years, investigators have really narrowed in on the role of TDP 43 in ALS,” Hesterlee explains. “It will be very interesting to see if blocking that aggregation would be useful. Until we've done the study we're not going to know, but it's certainly nice to see a drug that is trying this.”

Co-director of Massachusetts General Hospital’s Neurological Clinical Research Institute (NCRI), and co-principal investigator in the HEALEY Platform trial, Dr. Sabrina Paganoni, agrees that the candidate has an interesting target.

“This appears to be a promising drug and a very interesting target. I am hopeful if there are positive signals that the candidate could be explored further.”

AL-S Pharma candidate for both sporadic and familial patients

AL-S Pharma is investigating its candidate AP-101 in a Phase IIa trial (NCT05039099) in patients with familial amyotrophic lateral sclerosis (fALS) and sporadic amyotrophic lateral sclerosis (sALS).

The multicentre, randomised, double-blind, placebo-controlled study is evaluating safety, tolerability, pharmacodynamic (PD) markers, and pharmacokinetics (PK) of AP-101.

The study has a primary completion date in June 2024 with an estimated 63 patients.

AP-101 is an intravenous monoclonal antibody which acts by activating superoxide dismutase-1 (SOD1). Mutations in SOD1 leads to ALS.

The primary endpoints in the study are adverse events and abnormalities in vital signs while secondary endpoints will explore levels of cerebrospinal fluid (CSF), changes in neurofilament light chain and phospho-neurofilament heavy chain levels in CSF and plasma.

“It’s a bit of a different way of going after it. It's always good to try these pathways in different ways,” Hesterlee says.

RAPA Therapeutics investigates cell therapy

Rapa Therapeutics is running a Phase II/III trial (NCT04220190) of its candidate RAPA-501 . The trial is an open-label, non-randomised, multi-centre study evaluating RAPA-501 T cell therapy in patients with ALS.

RAPA-501 is an autologous T cell therapy which protects motor neuron cells from inflammation. The cells are manufactured ex vivo using epigenetic reprogramming to yield a T cell population that is enriched for a dual anti-inflammatory phenotype based on hybrid TREG and Th2 differentiation.

Patients are dosed with up to four infusions six weeks apart over the 30-week study. There are 41 patients planned to be enrolled in the trial which has a primary completion in July 2025.

“There is some evidence that T regulatory cells can be helpful in ALS, but it usually requires some kind of reprogramming,” says Hesterlee. “In this case, they're not doing any gene engineering but exposing the cells to change their expression patterns, and in theory become helpful in fighting the inflammation that you see in ALS. This looks interesting and is worth following to see how it works.”

Clene’s CNMAu-8 could be a ‘sprinkle of gold dust’

Clene’s CNMAu-8 is being investigated in a Phase II trial with a Phase III due to be launched in 2024 .

The Phase II trial (NCT05299658) is an open-label extension trial investigating the candidate in patients with early symptomatic ALS on stable background therapy. The oral candidate is administered once daily over a 48-week period. The trial is due to enrol 40 patients. The trial has a completion date in December 2024.

CNMAu-8 is an oral candidate developed with clean-surfaced, catalytically-active gold nanocrystals. The nanocrystalline suspension inhibits the ability of damaging events leading to dysmyelination and negatively regulates myelination and protects the neurons.

“CNM-Au8 has the ability to cross the blood-brain barrier, which allows it to successfully reach and protect neurons in the central nervous system,” Ali says. “Thus far, it has shown to be safe, well-tolerated and most importantly displays survival benefits, more than some other pipeline agents. Clene is all set for a Phase III to be launched in 2024. If it all works out for Clene, it could quite literally be a sprinkle of ‘’gold dust’’ for patients with ALS.”

Paganoni said that Clene’s candidate was investigated as one of the earlier regimens in the HEALEY trial. “It received a good signal in the platform trial and the company is pursuing that. It is definitely one to watch,” Paganoni explains.

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