For Consumers

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 disclaimer icon, "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 at the Webcast link below.

Webcast

http://fda.yorkcast.com/webcast/Play/2c4fd76553eb4ac6ae51ebef0dc910a81d disclaimer icon

Publications

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

Page Last Updated: 05/18/2018
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