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Gender Distribution in Device Clinical Trials: The FDA’s Increasing Emphasis on Sex-Specific Data
Despite FDA prodding, recent device clinical trials include only 22% women. Are you sure your clinical trials are gender-balanced?
If not you could be risking delayed or denied approvals, lawsuits from plaintiff’s attorneys… and some of the worst publicity you could imagine.
In August, the FDA issued its long-awaited draft guidance, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies,” 28 pages of recommendations that will steer device sponsors down a new path.
Plus, Congress is pushing this issue hard. On Nov. 17, a bipartisan group of US senators sent a letter to HHS asking for the inclusion of women in all phases of heart health research conducted by HHS, FDA, CDC and CMS, including analysis and publication of gender-specific data.
Two leading device researchers will help you understand and cope with this still-evolving area of government oversight. You’ll discover:
The presenters will spotlight how the new guidance may affect your trials — things to watch out for, stumbling-blocks to avoid.
Even today, three years after the FDA entered this area with its draft guidance on gender differences in clinical trials, devicemakers and clinical-trial design specialists still struggle with getting gender balance right.
Don’t jeopardize your device clinical trials. Order this timely webinar CD and transcript set, for the expert guidance that points you in a better direction.
Rita F. Redberg MD MSc, is Professor of Medicine, Director of Women’s Cardiovascular Services at UC-San Francisco and Chief Editor of JAMA Internal Medicine. Dr. Redberg has spearheaded the journal’s new focus on health care reform and a “less is more” approach that highlights areas of healthcare with no known benefit and definite risks. Her research focuses on high-value care employing high-risk medical devices, as well as the need to include women in clinical trials of such devices. She is often quoted in The New York Times, Wall Street Journal, USA Today and National Public Radio, and as a Today Show guest. A cardiologists, she also holds a MS in Health Policy and Administration from the London School of Economics.
Sanket Dhruva MD is a fellow in cardiology at UC-Davis Medical Center. He and Dr. Redberg have been researching gender disparities in medical-device clinical trials and FDA regulation, and Medicare coverage of medical devices, for the past seven years.
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