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The Great Debate: What is Enough … Women in Clinical Trials

The Great Debate: What is Enough ... Women in Clinical Trials

On May 16th, 2018, the FDA Office of Women’s Health sponsored a special event live and via webcast, "The Great Debate: What is Enough ... Women in Clinical Trials?". Taking place during National Women’s Health Week, the program began with a Keynote by FDA Commissioner Scott Gottlieb. The Great Debate centers on the challenges and complexity of the question “What is enough?” when determining participation of women in cardiovascular disease clinical trials.

The debate participants were two leading cardiovascular experts: Ellis F. Unger, M.D., FDA Center for Drug Evaluation and Research, and Rita Redberg, M.D., M.Sc., F.A.C.C., UCSF. It was a robust discussion centering on a complex question that has been debated among academia, federal, and non-government and consumer organizations for more than a quarter century. Watch a recording of the debate on the FDA YouTube Channel disclaimer icon using the links below.

The Great Debate (debate portion only) disclaimer icon - 1hr 1min

The Great Debate Commissioner's Keynote Address disclaimer icon - 10m 30sec

The Great Debate (complete recording) disclaimer icon - 1hr 22 min

Publications

Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs. J Am Coll Cardiol 2018;71:1960-1969. disclaimer icon

Speakers