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 participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
In the United States, an independent committee of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that that the risks are small and are worth the potential benefits.
As stated by the National Institutes of Health
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