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 using the links below.
The Great Debate (debate portion only) - 1hr 1min
The Great Debate Commissioner's Keynote Address - 10m 30sec
The Great Debate (complete recording) - 1hr 22 min
Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs. J Am Coll Cardiol 2018;71:1960-1969.