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
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.
Cancer.Net - What are Clinical Trials? with Richard Goldberg, MD - 3:50 minutes
In this patient education video, Dr. Richard Goldberg explains what clinical trials are, as well as their importance in finding new cancer treatments.
Cancer.Net - Phases of Cancer Clinical Trials – An Introduction - 4:45 minutes
Dr. Neal Meropol explains how clinical cancer research is done in distinct segments, called the phases of clinical trials.