The U.S. Food and Drug Administration (FDA) is looking to have more women involved in medical device clinical trials. The agency released draft guidance on the matter in the hopes of ensuring increased female representation in medical device clinical trials.
The agency believes that a number of factors may cause women to experience different responses to medical devices when compared to men, for instance, hormones, body size, diet genetics, illness types, and social and cultural factors, said Philly.com. These differences provide important information when device approval is being considered.
A 2009 study of several applications seeking approval for cardiovascular devices highlighted the issue. In those cases, in which important trials were being conducted, said Philly.com, average female enrollment, where gender information was included, as only 33.9 %. Also, a 2001 Government Accountability Office (DAO) report revealed that 52% of study participants were female; however, only 30% of those studies considered results based on participant gender, said Consumer Reports, which noted that the FDA believes medical device efficacy might differ by sex.
The FDA made its announcement about the recommended guidelines on December 16, said Consumer Reports. It is hoped that this move will not only help improve female representation in clinical trials, but that it will also better account for male-female differences when reviewing medical devices.
The agency’s draft guidance, which was written for medical device developers and manufacturers, contains recommendations for designing and conducting medical device clinical trials so that increased adult female representation is achieved, said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, wrote Philly.com. The guidance “covers study and evaluation of sex differences, data analysis, and reporting in clinical studies conducted both before and after market approval. It also deals with statistical analyses of sex differences, how to report sex-specific information in summaries, and sex-specific labeling for approved devices,” said Philly.com, which pointed out that there is a 90-day public comment period on the draft guidance.
“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies,” said Dr. Shuren in an FDA news release. “Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices,” he added.
According to the FDA’s, its Draft Guidance is meant “to outline the Center for Devices and Radiological Health’s (CDRH) expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The intent is to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by ensuring appropriate representation by sex in clinical studies of devices, and that data from such studies is appropriately analyzed for sex differences.”
The guidance can be accessed here.