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