Clinical Trials and U.S. Food and Drug Administration (FDA) Review
You group can support clinical trials by educating your patient community. There are also opportunities to inform the FDA during the clinical trials and marketing review process.
Toolkit Clinical Trials and FDA Review
Interventional clinical trials study the efficacy and safety of a potential therapy in humans. Studies are first performed in small groups of patients and then in larger patient populations. The goal of these clinical trials is to obtain data to support marketing approval. Marketing approval allows a medical product to be manufactured and sold outside of research studies.
In the United States, the U.S. Food and Drug Administration (FDA) regulates clinical trials and the sale of medical products. Your group can play an essential role in educating your community about clinical trials to ensure potential participants can make an informed decision. You can also contribute to the FDA monitoring and marketing review processes by providing input from the patients’ perspective.
Support Clinical Trials
Engage your patient community in the clinical trial process.
Serve on Review and Monitoring Boards
Understand the roles of Institutional Review Boards and Data Safety and Monitoring Boards.
Participate in FDA Advisory Meetings
Learn about ways your disease community can participate in FDA Advisory Committee meetings.