Study Finds Heart Device Trials Male-Dominated; FDA Promises Guidance
This article was originally published in The Gray Sheet
Executive Summary
Women remain underrepresented in pivotal studies of cardiac devices submitted to FDA, and there is a lack of analysis distinguishing between trial outcomes in men and women, researchers conclude in a study published online March 1.
You may also be interested in...
CDRH Launches ‘Health Of Women’ Program; Research Agenda To Focus On Ortho, Cardio Devices
The device center plans to develop a research roadmap to explore sex-based differences in outcomes to musculoskeletal and cardiovascular disease devices, as well as devices targeting diseases specific to women. CDRH launched the effort as part of its new “Health of Women” initiative at a June 24-25 workshop.
CDRH Launches ‘Health Of Women’ Program; Research Agenda To Focus On Ortho, Cardio Devices
The device center plans to develop a research roadmap to explore sex-based differences in outcomes to musculoskeletal and cardiovascular disease devices, as well as devices targeting diseases specific to women. CDRH launched the effort as part of its new “Health of Women” initiative at a workshop last week.
Need More Women For Device Trials? Create Better Consent Forms, FDA Says
Enrolling women and minorities in device trials remains a challenge. One potential solution highlighted at a recent FDA meeting: improve communication of potential treatment risks.