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About Clinical Studies

Research: it's all about patients.

Mayo's mission is about the patient, the patient comes first. So the mission and research here, is to advance how we can best help the patient, how to make sure the patient comes first in care. So in many ways, it's a cycle. It can start with as simple as an idea, worked on in a laboratory, brought to the patient bedside, and if everything goes right, and let's say it's helpful or beneficial, then brought on as a standard approach. And I think that is one of the unique characteristics of Mayo's approach to research, that patient-centeredness. That really helps to put it in its own spotlight.

At Mayo Clinic, the needs of the patient come first. Part of this commitment involves conducting medical research with the goal of helping patients live longer, healthier lives.

Through clinical studies, which involve people who volunteer to participate in them, researchers can better understand how to diagnose, treat and prevent diseases or conditions.

Types of clinical studies

• Observational study. A type of study in which people are observed or certain outcomes are measured. No attempt is made by the researcher to affect the outcome — for example, no treatment is given by the researcher.
• Clinical trial (interventional study). During clinical trials, researchers learn if a new test or treatment works and is safe. Treatments studied in clinical trials might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. Find out more about the five phases of non-cancer clinical trials on ClinicalTrials.gov or the National Cancer Institute phases of cancer trials .
• Medical records research. Medical records research involves the use of information collected from medical records. By studying the medical records of large groups of people over long periods of time, researchers can see how diseases progress and which treatments and surgeries work best. Find out more about Minnesota research authorization .

Clinical studies may differ from standard medical care

A health care provider diagnoses and treats existing illnesses or conditions based on current clinical practice guidelines and available, approved treatments.

But researchers are constantly looking for new and better ways to prevent and treat disease. In their laboratories, they explore ideas and test hypotheses through discovery science. Some of these ideas move into formal clinical trials.

During clinical studies, researchers formally and scientifically gather new knowledge and possibly translate these findings into improved patient care.

Before clinical trials begin

This video demonstrates how discovery science works, what happens in the research lab before clinical studies begin, and how a discovery is transformed into a potential therapy ready to be tested in trials with human participants:

How clinical trials work

Trace the clinical trial journey from a discovery research idea to a viable translatable treatment for patients:

See a glossary of terms related to clinical studies, clinical trials and medical research on ClinicalTrials.gov.

Watch a video about clinical studies to help you prepare to participate.

Let's Talk About Clinical Research

Narrator: This presentation is a brief introduction to the terms, purposes, benefits and risks of clinical research.

If you have questions about the content of this program, talk with your health care provider.

What is clinical research?

Clinical research is a process to find new and better ways to understand, detect, control and treat health conditions. The scientific method is used to find answers to difficult health-related questions.

Ways to participate

There are many ways to participate in clinical research at Mayo Clinic. Three common ways are by volunteering to be in a study, by giving permission to have your medical record reviewed for research purposes, and by allowing your blood or tissue samples to be studied.

Types of clinical research

There are many types of clinical research:

• Prevention studies look at ways to stop diseases from occurring or from recurring after successful treatment.
• Screening studies compare detection methods for common conditions.
• Diagnostic studies test methods for early identification of disease in those with symptoms.
• Treatment studies test new combinations of drugs and new approaches to surgery, radiation therapy and complementary medicine.
• The role of inheritance or genetic studies may be independent or part of other research.
• Quality of life studies explore ways to manage symptoms of chronic illness or side effects of treatment.
• Medical records studies review information from large groups of people.

Clinical research volunteers

Participants in clinical research volunteer to take part. Participants may be healthy, at high risk for developing a disease, or already diagnosed with a disease or illness. When a study is offered, individuals may choose whether or not to participate. If they choose to participate, they may leave the study at any time.

Research terms

You will hear many terms describing clinical research. These include research study, experiment, medical research and clinical trial.

Clinical trial

A clinical trial is research to answer specific questions about new therapies or new ways of using known treatments. Clinical trials take place in phases. For a treatment to become standard, it usually goes through two or three clinical trial phases. The early phases look at treatment safety. Later phases continue to look at safety and also determine the effectiveness of the treatment.

Phase I clinical trial

A small number of people participate in a phase I clinical trial. The goals are to determine safe dosages and methods of treatment delivery. This may be the first time the drug or intervention is used with people.

Phase II clinical trial

Phase II clinical trials have more participants. The goals are to evaluate the effectiveness of the treatment and to monitor side effects. Side effects are monitored in all the phases, but this is a special focus of phase II.

Phase III clinical trial

Phase III clinical trials have the largest number of participants and may take place in multiple health care centers. The goal of a phase III clinical trial is to compare the new treatment to the standard treatment. Sometimes the standard treatment is no treatment.

Phase IV clinical trial

A phase IV clinical trial may be conducted after U.S. Food and Drug Administration approval. The goal is to further assess the long-term safety and effectiveness of a therapy. Smaller numbers of participants may be enrolled if the disease is rare. Larger numbers will be enrolled for common diseases, such as diabetes or heart disease.

Clinical research sponsors

Mayo Clinic funds clinical research at facilities in Rochester, Minnesota; Jacksonville, Florida; and Arizona, and in the Mayo Clinic Health System. Clinical research is conducted in partnership with other medical centers throughout the world. Other sponsors of research at Mayo Clinic include the National Institutes of Health, device or pharmaceutical companies, foundations and organizations.

Clinical research at Mayo Clinic

Dr. Hugh Smith, former chair of Mayo Clinic Board of Governors, stated, "Our commitment to research is based on our knowledge that medicine must be constantly moving forward, that we need to continue our efforts to better understand disease and bring the latest medical knowledge to our practice and to our patients."

This fits with the term "translational research," meaning what is learned in the laboratory goes quickly to the patient's bedside and what is learned at the bedside is taken back to the laboratory.

Ethics and safety of clinical research

All clinical research conducted at Mayo Clinic is reviewed and approved by Mayo's Institutional Review Board. Multiple specialized committees and colleagues may also provide review of the research. Federal rules help ensure that clinical research is conducted in a safe and ethical manner.

Institutional review board

An institutional review board (IRB) reviews all clinical research proposals. The goal is to protect the welfare and safety of human subjects. The IRB continues its review as research is conducted.

Consent process

Participants sign a consent form to ensure that they understand key facts about a study. Such facts include that participation is voluntary and they may withdraw at any time. The consent form is an informational document, not a contract.

Study activities

Staff from the study team describe the research activities during the consent process. The research may include X-rays, blood tests, counseling or medications.

Study design

During the consent process, you may hear different phrases related to study design. Randomized means you will be assigned to a group by chance, much like a flip of a coin. In a single-blinded study, participants do not know which treatment they are receiving. In a double-blinded study, neither the participant nor the research team knows which treatment is being administered.

Some studies use an inactive substance called a placebo.

Multisite studies allow individuals from many different locations or health care centers to participate.

Remuneration

If the consent form states remuneration is provided, you will be paid for your time and participation in the study.

Some studies may involve additional cost. To address costs in a study, carefully review the consent form and discuss questions with the research team and your insurance company. Medicare may cover routine care costs that are part of clinical trials. Medicaid programs in some states may also provide routine care cost coverage, as well.

When considering participation in a research study, carefully look at the benefits and risks. Benefits may include earlier access to new clinical approaches and regular attention from a research team. Research participation often helps others in the future.

Risks/inconveniences

Risks may include side effects. The research treatment may be no better than the standard treatment. More visits, if required in the study, may be inconvenient.

Weigh your risks and benefits

Consider your situation as you weigh the risks and benefits of participation prior to enrolling and during the study. You may stop participation in the study at any time.

Ask questions

Stay informed while participating in research:

• Write down questions you want answered.
• If you do not understand, say so.
• If you have concerns, speak up.

Website resources are available. The first website lists clinical research at Mayo Clinic. The second website, provided by the National Institutes of Health, lists studies occurring in the United States and throughout the world.

Additional information about clinical research may be found at the Mayo Clinic Barbara Woodward Lips Patient Education Center and the Stephen and Barbara Slaggie Family Cancer Education Center.

Clinical studies questions

• Phone: 800-664-4542 (toll-free)
• Contact form

Cancer-related clinical studies questions

• Phone: 855-776-0015 (toll-free)

International patient clinical studies questions

• Phone: 507-284-8884
• Email: [email protected]

Clinical Studies in Depth

Learning all you can about clinical studies helps you prepare to participate.

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Understanding Clinical Trials

Clinical research: what is it.

Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. What is clinical research, and is it right for you?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.

At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. Once you understand more about clinical research, you may appreciate why it’s important to participate — for yourself and the community.

What Are the Types of Clinical Research?

There are two main kinds of clinical research:

Observational Studies

Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, such as tissue or blood provided by study participants.

Clinical Trials

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people.

Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.

Both healthy people and those with diagnosed medical conditions can take part in clinical research. Participation is always completely voluntary, and participants can leave a study at any time for any reason.

“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.” Liz Martinez, Johns Hopkins Medicine Research Participant Advocate

Types of Research Studies

Within the two main kinds of clinical research, there are many types of studies. They vary based on the study goals, participants and other factors.

Biospecimen studies

Healthy volunteer studies.

Clinical trials study the safety and effectiveness of interventions and procedures on people’s health. Interventions may include medications, radiation, foods or behaviors, such as exercise. Usually, the treatments in clinical trials are studied in a laboratory and sometimes in animals before they are studied in humans. The goal of clinical trials is to find new and better ways of preventing, diagnosing and treating disease. They are used to test:

Drugs or medicines

New types of surgery

Medical devices

New ways of using current treatments

New ways of changing health behaviors

New ways to improve quality of life for sick patients

 Goals of Clinical Trials

Because every clinical trial is designed to answer one or more medical questions, different trials have different goals. Those goals include:

Treatment trials

Prevention trials, screening trials, phases of a clinical trial.

In general, a new drug needs to go through a series of four types of clinical trials. This helps researchers show that the medication is safe and effective. As a study moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?   Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?   Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?  Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?   Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.” Gail Daumit, M.D., M.H.S., Vice Dean for Clinical Investigation, Johns Hopkins University School of Medicine

Is It Safe to Participate in Clinical Research?

There are several steps in place to protect volunteers who take part in clinical research studies. Clinical Research is regulated by the federal government. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.

Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. A protocol is a detailed plan of what researchers will do in during the study.

In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. IRB members also review plans for all clinical studies. And, they make sure that research participants are protected from as much risk as possible.

Earning Your Trust

This was not always the case. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. This includes medical research performed on enslaved people without their consent, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.

Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. In addition, Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research.

Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our Research Participant Advocacy Group .

Learn More About Clinical Research at Johns Hopkins Medicine

For information about clinical trial opportunities at Johns Hopkins Medicine, visit our trials site.

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Understanding Medical Research

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It seems to happen almost every day - you hear about the results of a new medical research study. Sometimes the results of one study seem to disagree with the results of another study.

It's important to be critical when reading or listening to reports of new medical findings. Some questions that can help you evaluate health information include:

• Was the study in animals or people?
• Does the study include people like you?
• How big was the study?
• Was it a randomized controlled clinical trial ?
• Where was the research done?
• If a new treatment was being tested, were there side effects?
• Who paid for the research?
• Who is reporting the results?

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Journal Articles References and abstracts from MEDLINE/PubMed (National Library of Medicine)

• Article: Considering Sex as a Variable at a Research University: Knowledge, Attitudes,...
• Article: Different domains of dengue research in the Philippines: A systematic review...
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Introduction.

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Different sections are needed in different types of scientific papers (lab reports, literature reviews, systematic reviews, methods papers, research papers, etc.). Projects that overlap with the social sciences or humanities may have different requirements. Generally, however, you'll need to include:

INTRODUCTION (Background)

METHODS SECTION (Materials and Methods)

What is a title

Titles have two functions: to identify the main topic or the message of the paper and to attract readers.

The title will be read by many people. Only a few will read the entire paper, therefore all words in the title should be chosen with care. Too short a title is not helpful to the potential reader. Too long a title can sometimes be even less meaningful. Remember a title is not an abstract. Neither is a title a sentence.

What makes a good title?

A good title is accurate, complete, and specific. Imagine searching for your paper in PubMed. What words would you use?

• Use the fewest possible words that describe the contents of the paper.
• Avoid waste words like "Studies on", or "Investigations on".
• Use specific terms rather than general.
• Use the same key terms in the title as the paper.
• Watch your word order and syntax.

The abstract is a miniature version of your paper. It should present the main story and a few essential details of the paper for readers who only look at the abstract and should serve as a clear preview for readers who read your whole paper. They are usually short (250 words or less).

The goal is to communicate:

•  What was done?
•  Why was it done?
•  How was it done?
•  What was found?

A good abstract is specific and selective. Try summarizing each of the sections of your paper in a sentence two. Do the abstract last, so you know exactly what you want to write.

• Use 1 or more well developed paragraphs.
• Use introduction/body/conclusion structure.
• Present purpose, results, conclusions and recommendations in that order.
• Make it understandable to a wide audience.
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A basic introduction to medical research. Part I: What is research and why do it?

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• 1 Research Council for Complementary Medicine, London, UK
• PMID: 9456715
• DOI: 10.1016/s1353-6117(05)80082-4

Our beliefs about health come from many sources, most of which come down to personal experience. This is often an unreliable way of finding out about health as it can be affected by the individual practitioner's own biases and beliefs. Moreover, changes observed in patients cannot always be ascribed to any treatments given. Research attempts to generate more reliable beliefs by carefully controlling for those factors likely to influence us incorrectly. Good research always starts by focusing on a question: what is the question which the researcher wants to answer? Questions enable the development of research designs. There is a particularly pressing need for good quality research in the complementary therapies typically used by nurses and midwives. We need to know: do the complementary therapies have specific effects on health? How should the therapies be used so that their effects are optimised? How should the therapies be used in health service settings? Unless these questions are answered, the use of complementary therapies by nurses and midwives is likely to remain sub-optimal.

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How to get involved in research as a medical student

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• Peer review
• Anna Kathryn Taylor , final year medical student 1 ,
• Sarah Purdy , professor of primary care and associate dean 1
• 1 Faculty of Health Sciences, University of Bristol, UK

Participating in research gives students great skills and opportunities. Anna Taylor and Sarah Purdy explain how to get started

This article contains:

-How to get involved with research projects

-Questions to ask yourself before starting research

-What can you get published? Research output

-Advice for contacting researchers

-Different types of research explained

-Stages of research projects

Students often go into medicine because of a desire to help others and improve patients’ physical and mental wellbeing. In the early years of medical school, however, it can seem as if you are not making much difference to patient care. Involvement in research can provide exciting opportunities to work as part of a team, improve career prospects, and most importantly add to the evidence base, leading to better outcomes for patients.

Research is usually multidisciplinary, including clinical academics (medical doctors who spend part of their working life doing research), nurses, patients, scientists, and researchers without a medical background. Involvement in such a team can improve your communication skills and expand your understanding of how a multidisciplinary team works.

Participating in research can also help you to develop skills in writing and critical appraisal through the process of publishing your work. You may be able to present your work at conferences—either as a poster or an oral presentation—and this can provide valuable points for job applications at both foundation programme and core training level. This is particularly important if you are considering a career in academia. You will also develop skills in time management, problem solving, and record keeping. You might discover an area of medicine in which you are keen to carry out further work. For some people, getting involved in research as a medical student can be the first step in an academic career.

Kyla Thomas, National Institute for Health Research clinical lecturer in public health at the University of Bristol, says, “my first baby steps into a clinical academic career started with a research project I completed as a medical student. That early involvement in research opened my eyes to a whole new world of opportunities that I never would have considered.

“Importantly, participating in undergraduate research sets students apart from their colleagues. Applying for foundation posts is a competitive process and it is a definite advantage if you have managed to obtain a peer reviewed publication.”

Getting involved with research projects

Although it is possible to do research at medical school, it is important to be realistic about how much free time you have. It might be possible to set up your own research project, but this will require substantial planning in terms of writing research protocols, gaining ethical approval, and learning about new research methodologies. Other opportunities for research that make less demands on your time include:

Intercalated degrees—these often have time set aside for research in a specific area, so it is important to choose your degree according to what you might like to do for your dissertation (for example, laboratory-based work in biochemistry, or qualitative research in global health. Some subjects may have options in both qualitative and quantitative research).

Student selected components or modules can provide a good opportunity to be involved in an ongoing study or research project. If you have a long project period, you might be able to develop your own small project.

Electives and summer holidays can also provide dedicated time for research, either within the United Kingdom or in another country. They can allow you to become established in a research group if you’re there for a few weeks, and can lead to a longstanding relationship with the research group if you continue to work with them over your medical school career.

If you don’t know what to do, contacting the Student Audit and Research in Surgery (STARSurg), 1 the National Student Association of Medical Research (NSAMR), 2 or your medical school’s research society may be a good place to start.

The INSPIRE initative, 3 coordinated by the Academy of Medical Sciences, gives support and grants to help students take part in research. Some UK medical schools have small grants for elective and summer projects, and organise taster days for students to get an idea of different research areas.

You may also be able to access other grants or awards to support your research. Some of the royal colleges, such as the Royal College of General Practitioners and the Royal College of Psychiatrists, offer bursaries to students doing research in their holidays or presenting at conferences. Other national organisations, such as the Medical Women’s Federation, offer bursaries for elective projects.

Box 1: Questions to ask yourself before starting research

What are you interested in? There is no point getting involved in a project area that you find boring.

How much time do you have available? It is crucial to think about this before committing to a project, so that your supervisor can give you an appropriate role.

What do you want to get out of your research experience? Do you want a brief insight into research? Or are you hoping for a publication or presentation?

Do you know any peers or senior medical students who are involved in research? Ask them about their experiences and whether they know of anyone who might be willing to include you in a project.

Box 2: Research output

Publication —This is the “gold standard” of output and usually consists of an article published in a PubMed ID journal. This can lead to your work being cited by another researcher for their paper, and you can get up to two extra points on foundation programme applications if you have published papers with a PubMed ID.

Not all research will get published, but there are other ways to show your work, such as presenting at conferences:

Oral presentation —This involves giving a short talk about your research, describing the background, methods, and results, then talking about the implications of your findings.

Poster presentation —This involves creating a poster, usually A1 or A2 in size, summarising the background, methods, and results of your research. At a conference, presenters stand by their poster and answer questions from other delegates.

Contacting researchers

Most universities have information about their research groups on their websites, so spend some time exploring what studies are being carried out and whether you are interested in one of the research topics.

When contacting a member of the research group, ask if they or someone else within their team would be willing to offer you some research experience. Be honest if you don’t have any prior experience and about the level of involvement you are looking for, but emphasise what it is about their research that interests you and why you want to work with them. It’s important to have a flexible approach to what they offer you—it may not initially sound very exciting, but it will be a necessary part of the research process, and may lead to more interesting research activity later.

Another way to make contact with researchers is at university talks or lectures. It might be intimidating to approach senior academics, but if you talk to them about your interest they will be more likely to remember you if you contact them later on.

Box 3: What can students offer research teams?—Views from researchers

“Medical students come to research with a ‘fresh eyes’ perspective and a questioning mindset regarding the realities of clinical practice which, as a non-medic myself, serves to remind me of the contextual challenges of implementing recommendations from our work.”

Alison Gregory, senior research associate, Centre for Academic Primary Care, University of Bristol, UK.

“Enthusiasm, intelligence, and a willingness to learn new skills to solve challenges—bring those attributes and you’ll be valuable to most research teams.”

Tony Pickering, consultant anaesthetist and Wellcome Trust senior research fellow, University of Bristol, UK.

Box 4: Different types of research

Research aims to achieve new insights into disease, investigations, and treatment, using methodologies such as the ones listed below:

Qualitative research —This can be used to develop a theory and to explain how and why people behave as they do. 4 It usually involves exploring the experience of illness, therapeutic interventions, or relationships, and can be compiled using focus groups, structured interviews, consultation analysis, 5 or ethnography. 6

Quantitative research —This aims to quantify a problem by generating numerical data, and may test a hypothesis. 7 Research projects can use chemicals, drugs, biological matter, or even computer generated models. Quantitative research might also involve using statistics to evaluate or compare interventions, such as in a randomised controlled trial.

Epidemiological research —This is the study of the occurrence and distribution of disease, the determinants influencing health and disease states, and the opportunities for prevention. It often involves the analysis of large datasets. 4

Mixed methods research —This form of research incorporates both quantitative and qualitative methodologies.

Systematic reviews —These provide a summary of the known evidence base around a particular research question. They often create new data by combining other quantitative (meta-analysis) or qualitative (meta-ethnography) studies. They are often used to inform clinical guidelines.

Box 5: Stages of research projects

Project conception—Come up with a hypothesis or an objective for the project and form the main research team.

Write the research protocol—Produce a detailed description of the methodology and gain ethical approval, if needed.

Carry out the methodology by collecting the data.

Analyse the data.

Decide on the best way to disseminate your findings—for example, a conference presentation or a publication—and where you will do this.

Write up your work, including an abstract, in the format required by your chosen journal or conference.

Submit . For conference abstracts, you may hear back swiftly whether you have been offered the chance to present. Publication submissions, however, must be peer reviewed before being accepted and it can take over a year for a paper to appear in print.

Originally published as: Student BMJ 2017;25:i6593

Competing interests: AKT received grant money from INSPIRE in 2013.

Provenance and peer review: Not commissioned; externally peer reviewed.

• ↵ STARSurg. Student Audit and Research in Surgery. 2016. www.starsurg.org .
• ↵ NSAMR. National Student Association of Medical Research. 2016. www.nsamr.org .
• ↵ The Academy of Medical Sciences. About the INSPIRE initiative. 2016. www.acmedsci.ac.uk/careers/mentoring-and-careers/INSPIRE/about-INSPIRE/ .
• ↵ Ben-Shlomo Y, Brookes ST, Hickman M. Lecture Notes: Epidemiology, Evidence-based Medicine and Public Health. 6th ed . Wiley-Blackwell, 2013 .
• ↵ gp-training.net. Consultation Theory. 2016. www.gp-training.net/training/communication_skills/consultation/consultation_theory.htm .
• ↵ Reeves S, Kuper A, Hodges BD. Qualitative research methodologies: ethnography. BMJ 2008 ; 337 : a1020 . doi:10.1136/bmj.a1020   pmid:18687725 . OpenUrl FREE Full Text
• ↵ Porta M. A Dictionary of Epidemiology. 5th ed . Oxford University Press, 2008 .

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• / The Human Body in Research

Systems of the Human Body in Research and Education

Virtually every organ, tissue and system of the human body is needed for medical research, and nearly every disease that plagues mankind is being studied with the help of donated human organs and tissues.

Many organs act as the focal points of regenerative medicine, such as organs being decellularized to rid them of either diseased or potentially incompatible cells and later recellularized with a recipient’s own cells for eventual transplantation.

Virtually all organs are studied to identify precursors to a multitude of diseases. Through this incredible research, preventative care can be introduced to a patient well before their organs begin to fail and they face the need for an organ transplant or, in extreme circumstances, death.

Please see the downloadable diagram below for the complete list of organs and tissues for research available through IIAM. 

Used to study the influence of hormones on cardiovascular disease.

For studies on the congenital defects of the kidney and urinary tract as a major cause of pediatric renal failure. The bladder is also studied to test new compounds to cure urinary incontinence.

For studies of genetic markers, inflammatory diseases and central nervous system disorders.

Heart, Aorta, Arteries and Veins

Medical investigators use the human heart to learn about the development of atherosclerosis in coronary arteries. These and other blood vessels are used to find ways to control clot formation and high blood pressure. Ground-breaking research for bypass procedures and the development of plaque-removal devices and improved imaging methods is also underway.

Renal tissue is used to study the toxicity of anti-cancer therapies, for example, and to study the safe concentrations of other drugs in development. Kidneys are also used to identify new biomarkers to determine their transplantability and to produce safer cold preservation methods.

The liver is responsible for most drug and chemical metabolism, and is the site of drug-drug interaction and toxicity. IIAM has been a leader in providing whole, human livers to help researchers understand how human livers respond to various drugs, to develop effective screening assays for anti-HCV drugs, and to reduce researchers’ reliance on animal testing.

Research into chronic obstructive pulmonary disease (COPD), cystic fibrosis, asthma, emphysema and allergies are advanced by the use of human lung tissues. In addition, researchers are testing the potential for new drugs to cause broncho-constriction of airways thus preventing possible life-threatening events.

Diabetes researchers rely on pancreatic tissues to explore the regulation of insulin production, to identify the genetic components of the disease and for toxicity studies on new compounds. Researchers are also seeking ways to prevent and cure Types I & II Diabetes. Transplantation of islet cells, the site of insulin production, is undergoing clinical trials with very promising results.

Researchers examining human skin to study comparative rates of drug absorption have developed such novel approaches as transdermal or “patch” delivery, as well as topical applications, for a variety of drug types.

As a prolific source of T-cells and B-cells, the human spleen is used by researchers to investigate AIDS and other autoimmune diseases and for tolerance studies.

Utilized in the study of gastro-esophageal reflux diseases (GERD), and to explore the side effects of new drugs for gastric disorders.

For antibody studies on human T-cells.

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Phenotyping Down syndrome: discovery and predictive modelling with electronic medical records

Apr 22, 2024, 2:52 AM

Nguyen, T. Q., Kerley, C. I., Key, A. P., Maxwell-Horn, A. C., Wells, Q. S., Neul, J. L., Cutting, L. E., & Landman, B. A. (2024). Phenotyping Down syndrome: discovery and predictive modelling with electronic medical records. Journal of Intellectual Disability Research. https://doi.org/10.1111/JIR.13124

A comprehensive two-part study utilizing electronic medical records from Vanderbilt University Medical Center investigated health conditions in individuals with Down syndrome (DS), particularly those with congenital heart disease (CHD). The first part of the study examined a large cohort of DS individuals, revealing a higher prevalence of specific health issues such as heart failure, pulmonary heart disease, and hypothyroidism compared to controls and those with other intellectual and developmental disabilities. The second part focused on DS patients with CHD, identifying conditions like congestive heart failure and valvular heart disease that increased the likelihood of surgical interventions. These findings highlight the complex health profiles of individuals with DS, suggesting the need for tailored medical approaches to better manage their multiple health challenges.

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Can this thumb test tell if you are at increased risk of a hidden aortic aneurysm?

by Dan Baumgardt, The Conversation

All the parts of our bodies share an inherent connectivity. This goes much further than "the foot bone's connected to the … leg bone." For instance, both hands and feet are connected to a constantly flowing bloodstream, and a nerve network that makes their muscles kick.

So what about the connection recently proposed by some news outlets regarding a simple test involving your palm and thumb? Could it really help diagnose a silent, yet potentially serious problem?

An aneurysm is what we're referring to here. This is a ballooned segment of an artery—the vessels that supply oxygenated blood to your body tissues. Aneurysms may cause no problems, but if they grow larger, they can weaken, burst and bleed. This is bad enough in most arteries, but imagine if the artery involved were the biggest in your body?

The vessel in question is the aorta. Aortic aneurysms can develop slowly and insidiously, without yielding any knowledge that they are evolving, since they may not trigger any symptoms.

Indeed, they may not become identifiable until they're starting to leak. By this stage, the threat to life from arterial rupture is severe.

Any test that can pick up an aneurysm before it gets to this danger point has great implications. Namely, so the defect can be closely monitored and repaired if needed.

So, is there a clinical basis for this proposed test? And what does it involve?

The thumb-palm test

The original paper regarding the problem dates to 2021. A research group in the U.S. recognized that some people with aortic aneurysms demonstrated a sign in their hands when asked to cross their thumb across a flattened palm. A positive test was seen when the thumb extended all the way across the palm, protruding to the other side.

A link could be made between this finding and the presence of a connective tissue disorder, where joints and ligaments are lax and loose, and might lead to a positive test. Some connective tissue disorders, including Marfan syndrome , are known to be associated with developing aneurysms, so this observation made sense.

The findings were that a positive test was associated with a high likelihood of an aneurysm being present in the ascending portion of the aorta as it leaves the heart.

However, it's important to note that the landmark paper examining the relationship looked at 305 patients. Of these, 10 showed the positive sign, so the sample size could have affected the results.

That's not to say that this test lacks credibility, but it needs to be tested on more patients first.

And it's not the only example of a test used in medical practice that is not perfect.

What makes a good test?

In medicine, we ideally want to use tests that accurately spot diseases without missing them. We also want those that don't misdiagnose patients, and are specific to certain conditions. We call these important parameters the sensitivity and specificity . Ideally, both should be as high as possible for a test to be considered a gold standard.

In reality, there are many tests we use that lack sensitivity or specificity. Take prostate-specific antigen (PSA) for instance—a simple blood screening test available to screen for prostate cancer. If the PSA comes back raised (and this is variable according to age ) one of the underlying diagnoses might be prostate cancer.

But it also might be an enlarged or inflamed prostate, or a urinary tract infection. Or recent sexual intercourse. Or indeed, (but more speculatively) cycling before the test.

Many factors aside from cancer can cause a raised PSA, making the test lack specificity. PSA can also sometimes be normal in patients with prostate cancer , which means it lacks sensitivity.

This is why doctors have to use test results alongside other clues , such as examining the prostate to see if it is enlarged and craggy to the touch—altogether more suggestive of cancer.

Like PSA, what is known about the thumb-palm test shows it has to be interpreted correctly. Those with positive tests do not always have an aortic aneurysm. And having a negative test doesn't automatically exclude one. It also needs to be performed correctly: the palm must be flat, not folded, to prevent a false positive test.

But what does this all mean for detecting aortic aneurysms while more research is carried out? Perhaps we should be considering what is known about them.

We know that this condition is associated with high blood pressure, high cholesterol and smoking —so identifying and treating risk factors is important.

Equally important is scanning the aorta of those at-risk groups; those with certain connective tissue disorders or with a family history of aortic aneurysms .

The thumb-palm test has yet to be incorporated into clinical practice, but further research looking at larger patient populations might allow it some more credence. In the meantime, we must rely on what we do know, to detect them as early as possible, and monitor them lest they become dangerous.

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ABC News’ Becky Worley joins research study that could help millions of others

Worley is now a part of an effort to study over 1 million people in the U.S.

Becky Worley is an ABC News correspondent based in California. Here, she documents her experience as a participant in the All of Us Research Program , a National Institutes of Health project that aims to study more than 1 million people from all backgrounds.

It started like most " Good Morning America " assignments, an idea from our Med Unit about a new study being conducted by the National Institutes of Health .

They pitched the "All of Us" study to our editorial group, and I was asked to bring the story to air. But in the end, it was unlike any story I've ever done.

I became a participant and learned a lot about myself and public health in the process.

The National Institute of Health's All of Us Research Program will collect more data on more types of people than ever before.

There are currently 800,000 people enrolled and they're hoping to reach a million or more. They've collected over four petabytes of data with the goal of broadening our understanding of disease, medicine, and wellness by including data that's only now becoming feasible to analyze through advanced computing technology and data collection methods.

And perhaps more important than the new tech, they want to break new ground, including a more representative swath of our diverse population, according to Sheri Schully, deputy chief medical and scientific officer for the All of Us Research Program.

"The hope for the impact is that we will be generating evidence on people who have traditionally not been part of biomedical research, so that eventually clinical care can be more personalized for everyone," she said. "So, that's not only racial and ethnic minorities, but also sexual gender minorities, rural populations versus urban populations, lower income, lower education attainment, we can gather the evidence to really drive clinical practice for everyone."

Like every other participant, I signed up online at joinallofus.org , and once instructed to do so, I headed to one of the study's regional provider sites at the University of California Davis Medical Center.

Over the course of two visits, they took blood samples, gave me a wearable device to track my activity and sleep, checked my weight and body fat percentage, analyzed my microbiome, gathered a saliva sample, clipped my toenails to gather DNA and even snipped a hair sample, which I was told provides information about environmental toxin exposure, and is an optional part of the study.

MORE: Women not getting equal medical advice when it comes to heart health, study finds

I filled out pages and pages of information about my daily habits, medical history, and family history. I consented to let the researchers access my medical health records. I wore a glucose monitor and logged everything I ate for a week.

The amount of work that goes into this is not small, but the benefits both for society and me as an individual seem worth it.

The massive amounts of data are anonymized and made available to researchers who apply for access so that they can use this large data set as they develop new medicines, new diagnostic tests, and new treatments for disease. Study organizers say the data will shape public health policy for decades. Because the study is aiming to reach out to a more diverse population, the hope is that new medical discoveries will be less specific to those white, straight, typically abled, suburban/urban, highly educated participants who have historically participated in clinical trials, and will better represent our diverse population.

Scientists from this study have already unearthed more than 275,000,000 previously unreported genetic variants, half of which are from participants of non-European genetic ancestry. This could have huge impacts on personalized medicine in the future that identifies health patterns from genetic markers and a corresponding tailored standard of care.

MORE: COVID-19 puts spotlight on disparities in research on women's health

Beyond the research benefit, each participant gains access to a large amount of data about themselves.

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"We're returning 59 variants and 59 genes where we know there's action that can be taken if you have a variant and one of those genes," Schully said. "So for example, we are returning results from the breast cancer genes, BRCA, 1 and 2, [and] those are actually returned through a genetic counselor … so that participants can really get their questions answered by a professional who is used to returning results like this."

I felt incredibly relieved when my results came back clear; no genetic mutations that I needed to talk about with my doctor. But there was also a report based on my DNA about which medicines I may not process well.

One of the drugs I may not process well is a chemotherapy drug, and it could someday be incredibly helpful to know that I should opt for an alternative if I need cancer care.

The program directors told me that all the data is anonymized for research and is kept in the cloud with serious security.

They also addressed the elephant in the room: They know many underrepresented Americans have a deep distrust of medical research because of so many historical injustices. They said they have a diverse group of advisers and stakeholders who take the issues seriously and ask for participants' trust, a point emphasized by Schully.

"Trust is something that we put at the very forefront. It's one of our core values as a program, and we partner with community-based organizations that are within communities where there has been distrust with research," she said. "We make an effort to make sure that participants are at the very center of everything we do."

For me, I gained a lot of perspective on my health and the typically inscrutable information in my DNA that may predict future health challenges.

I feel like I can provide important information to my kids about their genetic information, and I know I did something to help science and the future of medicine.

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Institute of Medicine (US) Clinical Research Roundtable; Tunis S, Korn A, Ommaya A, editors. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington (DC): National Academies Press (US); 2002.

The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary.

• Hardcopy Version at National Academies Press

Appendix V Definitions of Clinical Research and Components of the Enterprise

• DEFINITION OF CLINICAL RESEARCH

(Clinical Research: A National Call to Action, November 1999) Clinical research is a component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness, and promoting health. Clinical Research embraces a continuum of studies involving interactions with patients, diagnostic clinical materials or data, or populations in any of the following categories: (1) disease mechanisms (etiopathogenesis); (2) bi-directional integrative (translational) research; (3) clinical knowledge, detection, diagnosis and natural history of disease; (4) therapeutic interventions including development and clinical trials of drugs, biologics, devices, and instruments; (5) prevention (primary and secondary) and health promotion; (6) behavioral research; (7) health services research, including outcomes, and cost-effectiveness; (8) epidemiology; and (9) community-based and managed care-based trials.

• MAJOR COMPONENTS OF THE CLINICAL RESEARCH ENTERPRISE

Sponsors include private and public sector funding organizations such as the National Institutes of Health, pharmaceutical companies, medical device manufacturers, biotechnology firms, universities, private foundations, and national societies. Within the public sector the National Institutes of Health (NIH) is the largest clinical research sponsor, followed by the Department of Defense (DOD), the Department of Veterans Affairs (VA), Agency for Healthcare Research and Quality (AHRQ), and the Centers for Disease Control (CDC).

Research Organizations

Research organizations include academic health centers, private research institutes, survey research organizations, federal government intramural research programs, and contract research organizations.

Investigators

Investigators are the scientists performing clinical research from varied disciplines with a range of academic qualifications (e.g., MD, Ph.D., RN, DDS, PharmD).

Participants

Participants are the human volunteers, medical information and biological materials of human origin, or data derived from volunteers. Participants may have particular health conditions or may be healthy volunteers or populations at large.

Oversight Entities

Oversight entities include Institutional Review Boards, Food and Drug Administration, Department of Health and Human Services, Veterans Affairs, National Committee for Quality Assurance, and other national regulatory agencies.

Stakeholders/Consumers

Stakeholders/Consumers include health insurers, managed care organizations, health care systems, organized medicine, voluntary health agencies, patient advocacy groups, purchasers of health care, and providers of health care, public health systems, and individual consumers.

• Cite this Page Institute of Medicine (US) Clinical Research Roundtable; Tunis S, Korn A, Ommaya A, editors. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington (DC): National Academies Press (US); 2002. Appendix V, Definitions of Clinical Research and Components of the Enterprise.
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• Geriatric Medication Safety Symposium Focuses on Transitions of Care

Research News

Third Year of Geriatric Medication Safety Symposium Focuses on Transitions of Care in Older Adult Population

May 6 — More than 120 practitioners, researchers, students and postdoctoral trainees exchanged insights into "Optimizing Safety in Care Transitions for Older Adults" during the 2024 Geriatric Medication Safety Symposium April 25-26 at UTHealth Houston's Cooley University Life Center in Houston's Texas Medical Center.

In its third year, the event drew in-person and online participants from fellow Texas Medical Center institutions and community organizations from across the Greater Houston area and beyond. The symposium featured four plenary sessions and two workshops from the perspectives of nursing, pharmacy, medicine and dentistry, which also provided continuing education credits to attendees. In addition, early-stage faculty members, graduate and professional program students, and postdoctoral residents and fellows presented 21 posters and four podium talks on their research.

Funded by a five-year grant from the National Institute on Aging, the symposium was co-chaired by Rajender R. Aparasu, Ph.D., FAPhA, University of Houston College of Pharmacy Mustafa F. & Sanober Lokhandwala Professor and chair of the Department Pharmaceutical Health Outcomes and Policy, and Holly M. Holmes, M.D., M.S., AGSF, Joan & Stanford Alexander Chair in Gerontology, professor and division director, Joan & Stanford Alexander Division of Geriatric and Palliative Medicine at UTHealth McGovern School of Medicine. 

"The response of health care professionals and investigators committed to improving the quality of care and quality of life of our older patients by sharing our experiences and research has been tremendous," Aparasu said. "I commend our outstanding plenary session and workshop leaders for offering their expertise on highly relevant and timely topics as well as the thoughtful, high-quality studies conducted by our podium and poster presenters."

Leading the plenary talks and workshops were:

• Michelle A. Chui, Pharm.D., Ph.D., FAPhA, Hammel-Sanders Distinguished Professor in the Social & Administrative Sciences Division in the University of Wisconsin-Madison School of Pharmacy, who presented the workshop, "Implementation Science to Improve Medication Safety," and plenary session, "Health IT Tools & Implementation to Improve Geriatric Medication Safety"
• Yong-Fang Kuo, Ph.D., professor and chair of the Department of Biostatistics & Data Science at the University of Texas Medical Branch (UTMB), who presented the plenary session, "Medication prescribing by nurse practitioners"
• Timothy P. McNeill, R.N., MPH, founder of consulting firm Freedmen's Health, who gave the plenary talk on "Deploying interventions to address health-related social needs (HRSNs) to improve medication adherence during transitions of care"
• Amanda S. Mixon, M.D., M.S., MSPH, associate professor of medicine and bioinformatics at Vanderbilt University, who shared the plenary presentation, "Lessons Learned from Multi-site Medications Reconciliation Studies"
• June Sadowsky, DDS, MPH, professor and dentist geriatrician at UTHealth School of Dentistry, who led the workshop, "Dentistry: Transitions in the Caring of the Elder Population"

Two participants were recognized for excellence in research presentations:

Bilqees Fatima, Pharm.D., M.S., UHCOP Ph.D. in Pharmaceutical Sciences-Pharmaceutical Health Outcomes and Policy Concentration candidate, won Best Poster Award for her project, "Group-Based Trajectory Modeling for Assessing Oral Endocrine Therapy Adherence Pattern in HER-positive Breast Cancer Patients at DHR Health in the Rio Grande Valley"

Sadaf Milani, Ph.D., MPH, University of Texas Medical Branch Department of Internal Medicine assistant professor of geriatrics, won Best Podium Presentation for her project, "The Association of Dementia Medications with Pain Medication in Dementia Patients with Chronic Pain."

A new mother's immune status varies with her feeding strategy

In one of the first studies of its kind, UC Santa Barbara researchers have found that the immune status of postpartum mothers shifts with how she feeds her baby. According to a paper published in the journal Scientific Reports , certain inflammatory proteins -- substances that are secreted as part of an immune response -- peak at different times of day, correlating with whether the mothers breastfeed, pump or formula-feed their babies.

"It's a great study; there are so many unanswered questions about maternal health in the postpartum period," said Amy Boddy, a human biologist and evolutionary theorist at UCSB's Department of Anthropology, and senior author of the paper. It's a rare deep look at immunity from the postpartum mother's perspective, which she hopes will become a springboard for future research.

Indeed, she said, much of the research on the effects of breastfeeding concentrate on the infant, with many findings that demonstrate benefits of breastfeeding to the baby's immunity and development. In the longer term, mothers who have breastfed also have a lower risk for developing certain cancers and diabetes.

But how about women within the crucial first months to years after childbirth? To investigate, Boddy, lead author and co-Principal Investigator Carmen Hové and team followed a population of 96 women in the Seattle area who had given birth within the previous six months and collected their saliva twice over a 24-hour period, once before going to bed, and again in the morning after waking. Because the COVID-19 pandemic had just hit and everyone was on lockdown, the researchers found themselves with an unexpectedly ideal experimental situation, in which the mothers' environments were heavily controlled for infections which could confound the immunity readings.

"It was kind of a perfect natural experiment, because we're looking at immune function and of the reports, no one was sick," Boddy said. The goal? To follow cyclical levels of five types of proteins (labeled CRP, IL-1β. IL-6, IL-8 and TNF-α) that indicate inflammation that is a marker of immune response.

"It's been shown before that breastfeeding has a suite of inflammatory responses to it," Boddy explained. "Inflammation isn't always a bad thing -- the breast is remodeling, functioning and doing things in the body." The proteins' diurnal patterns meant that generally speaking, concentrations are typically higher in the mornings and lower in the evenings. What the researchers were interested in was seeing out-of-the-ordinary levels in the normal ebb and flow of these proteins and how they matched up with the new mothers' infant feeding strategies.

For several proteins, there were no measurable deviances in the morning and evening levels no matter whether the mothers pumped or breastfed. However, for the C-reactive protein (CRP) the researchers found that levels peaked in the evenings for women who relied heavily on breastfeeding, reversing the normal diurnal trend.

"We expected that low rates of lactating would be associated with a relatively high morning peak in CRP and vice versa,"Hové said. "What we ended up finding is that among mothers who reported intensive lactation, via either breastfeeding or pumping, CRP was higher at nighttime." More research is needed to determine the precise effects of this unique pattern in breastfeeding or lactating mothers, she added.

"We don't know exactly what's going on here," Boddy said, "maybe not emptying your breast fully, leads to inflammation." Or maybe it's the other direction, and the inflammation is a healing response from pregnancy. Maybe the incomplete emptying is a change of behavior due to stress. Perhaps the stress is the result of interrupted sleep that comes with round-the-clock breastfeeding schedules. "We don't have the causal arrow of what's going on; it's just an association," she said. "This study shows that there is a unique immune profile, and we should study this in more detail."

What this study reveals is the true complexity of postpartum breastfeeding. Breastfeeding is part of an ongoing physiological negotiation between mother and the new baby which favors the infant, Boddy said.

"There's something in evolutionary biology called maternal-fetal conflict. The idea is, when you've two bodies in one maternal unit, that the baby always wants a little more than the mother has to give," she explained. This research dives into the gray area of postpartum health from the mother's perspective, particularly in the realm of breastfeeding and immunity.

Indeed, despite the ideal, long promoted by institutes such as the World Health Organization that "breast is best," the researchers found that even from their sample of educated, relatively affluent women, there existed a combination of lactation feeding strategies, highlighting challenges of exclusive at-the-nipple feeding.

"There's been a lot of pushback, mostly from lactating mothers, centered around time constraints. Our society doesn't make it easy for us to actually breastfeed and have lactational support," said Boddy, who nursed both her children as infants and found it "challenging to meet breastfeeding goals." In addition, the guidelines aren't clear on when breastfeeding should end. When do the physiological and other benefits diminish for the mother in this ongoing negotiation, which could last years? Could this information yield some insight on other trends, such as maternal mortality?

The researchers hope to study the topic more deeply, and on a more individual level, to tease out further patterns in postpartum health and breastfeeding, such as with the various hormones involved in lactation.

"I think this study has opened up more questions than what we've answered. What we would like to do is follow some of these same women throughout the course of their postpartum experience," Boddy said. "It's always been challenging to find the best way of feeding our babies and breastfeeding is so demanding."

• Breastfeeding
• Infant's Health
• Immune System
• Pregnancy and Childbirth
• Teen Health
• Medical Topics
• Diseases and Conditions
• Postpartum depression
• Immune system
• Chemotherapy
• Rheumatoid arthritis
• Maternal bond
• Natural killer cell

Story Source:

Materials provided by University of California - Santa Barbara . Original written by Sonia Fernandez. Note: Content may be edited for style and length.

Journal Reference :

• Carmen Hove, Kristine Joy Chua, Melanie Ann Martin, Madison Hubble, Amy M. Boddy. Variation in maternal lactation practices associated with changes in diurnal maternal inflammation . Scientific Reports , 2024; 14 (1) DOI: 10.1038/s41598-024-54963-4

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