Gender Distribution in Device Clinical Trials - Webinar CD/Transcript
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In August, the FDA issued its long-awaited draft guidance, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies,” 28 pages of recommendations that will steer device sponsors down a new path.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 FDA’s two key moves to reduce gender disparities in device clinical trials
- Three case studies where medical devices were approved from data in men — and women did much worse
- Strategies to increase representation of women in your device clinical trials
- Strategies to incorporate gender-specific data in clinical decision-making
- And much more!
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Even today, three years after the FDA entered this area with its draft guidance on gender differences in clinical trials, devicemakers and clinical-trial design specialists still struggle with getting gender balance right.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.