The FDA has released draft guidance aimed at increasing the number of women participating in clinical trials for medical devices.
Clinical trials tend to under-represent women, the agency explained in a Dec. 16 statement, which added, "This represents a shortcoming in typical study design because medical products may affect women differently than men due to genetics, hormones, body size, diet, social and cultural factors, and types of illness."
The release pointed to a 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies showing that, while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics.
The draft guidance addresses study and evaluation of sex differences, data analysis and reporting in studies performed both before and after FDA approval. It also covers issues around statistical analyses of sex differences and how to report sex-specific information in summaries, along with labeling for approved devices.
“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices.”
The FDA is seeking input during a 90-day comment period beginning Dec. 19. The draft guidance is posted here.