Clinical Trials

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 that consists of members from three distinct areas that include scientific training, non-scientific backgrounds and community members. Its role is to make sure that the study is ethical, protect the rights and welfare of the participants and 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.