Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to:
- Make sure that the study is ethical
- Protect the rights and welfare of the participants
- Make sure that the risks are reasonable when compared to the potential benefits
In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.
NIH: National Institutes of Health
- Clinical Trial Basics (National Institutes of Health)
- Frequently Asked Questions about Clinical Research (National Human Genome Research Institute)
- How Clinical Trials Work (National Heart, Lung, and Blood Institute)
- Are Clinical Studies for You? (National Institutes of Health, Clinical Center)
- Cancer Clinical Trials at the National Institutes of Health Clinical Center (National Cancer Institute) Also in Spanish
- Clinical Trials -- Information for Participants (National Institute of Mental Health) Also in Spanish
- Clinical Trials: Benefits, Risks, and Safety (National Institute on Aging)
- Participating in Alzheimer's Disease Research (National Institute on Aging)
- Placebos in Clinical Trials (National Institute on Aging)
- Volunteer Stories (National Institutes of Health)
Videos and Tutorials
- Should I Participate in a Clinical Trial? What's in It for Me? (National Institutes of Health)
- What Is a Clinical Trial? (National Institutes of Health) Also in Spanish
Journal Articles References and abstracts from MEDLINE/PubMed (National Library of Medicine)
- Article: Re-engineering a Clinical Trial Management System Using Blockchain Technology: System Design,...
- Article: Challenges of Conducting Clinical Trials during the SARS-CoV-2 Pandemic: The ASCEND...
- Article: Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis.
- Clinical Trials -- see more articles
- Glossary of Common Site Terms (National Institutes of Health)
- Children's Assent to Clinical Trial Participation (National Cancer Institute)