FDA addresses gender data disparity in device trials

The Center for Devices and Radiological Health, the FDA's device center, is proactively working to reduce the gender information gap apparent in some clinical trials. In a retrospective analysis of cardiac resynchronization therapy trials, the agency determined that women benefit from the therapy more than men. While women showed up to 76% reduction of heart failure and death--compared to the insignificant effects of the device on men--the differences in gender-based results were not easily highlighted because a mere 22% of the heart failure patients in the trial were female. The study was published in JAMA: Internal Medicine and is the agency's first individual patient-level analysis of data involving devices from multiple companies, said CDRH's Dr. David Strauss. The agency plans to finalize a guidance document about data collection practices on women participating in device trials and will soon issue a congressionally mandated action plan on the topic. FDA's Blog