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FDA proposes draft guidelines intended to improve representation of women in clinical studies
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Draft guidance aimed to address the underrepresentation of women in medical device clinical studies was issued recently by the FDA. Intended for developers and manufacturers of medical devices, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.
“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies. Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices,” Jeffrey Shuren, MD, director of the FDA Center for Devices and Radiological Health, stated in a press release.
Certain medical products may elicit different responses in women than in men. This may be due in part to basic differences in women and men, including genetics, hormones, body size, diet and sociocultural issues. In addition, certain variables associated with women, such as size or certain illnesses, may be responsible for certain differences between women and men in the safety and effectiveness of medical devices.
The agency released referenced a 2011 report by the US Government Accountability Office on FDA-reviewed drug studies that found that while women represented 52% of study enrollees, 30% of study documents did not report outcomes by sex and nearly 40% did not report enrollment demographics. A 2009 study of CV device pre-market applications showed that pivotal studies that reported sex enrolled an average of 33.9% women.
The draft guidance addresses study and evaluation of sex differences, data analysis and reporting in both pre- and post-market device clinical studies. In addition, it covers issues regarding statistical analyses of sex differences and how to report sex-specific information in summaries and labeling for approved devices, according to information in the release.
The FDA is seeking input on this draft guidance during a 90-day public comment period. The draft guidance can be found here.
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