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)
- Clinical Trials (National Heart, Lung, and Blood Institute)
- Frequently Asked Questions about Clinical Research (National Human Genome Research Institute)
- NIH Clinical Research Trials and You (National Institutes of Health)
- What Are Clinical Trials and Studies? (National Institute on Aging)
- 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)
- 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)
Journal Articles References and abstracts from MEDLINE/PubMed (National Library of Medicine)
- Glossary of Common Site Terms (National Institutes of Health)
- Children's Assent to Clinical Trial Participation (National Cancer Institute)