What is a Clinical Trial?

A clinical trial is a research study in human volunteers designed to answer specific health questions. Clinical trials provide patients with access to new treatments that are still in the testing phase. People who participate in clinical trials can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Clinical Trial Oversight
Clinical trials at each hospital are the responsibility of a team of people. A clinical trial team includes doctors, nurses and other healthcare professionals who will check your health before the trial, give you instructions about participating, oversee your progress during the trial should you choose to participate, and stay in touch with you after the trial is done.

Clinical trials are reviewed and approved by each hospital before the trial can begin. This review process is designed to protect the rights and welfare of patients involved in a clinical trial.

All clinical trial requirements are set by the U.S. Food and Drug Administration, or FDA. The FDA establishes these regulations to protect patients and provides guidelines for companies, hospitals, doctors and nurses who are part of the clinical trial team.

To learn more about clinical trials, visit the FDA's website at: http://www.fda.gov/oashi/clinicaltrials/default.htm