Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration on December 16.

Intended for medical device developers and manufacturers, 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,” said Jeffrey Shuren, M.D., 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 “Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices.”

Certain medical products may elicit different responses in women than in men. This may be due in part to basic differences in men and women, 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 men and women in the safety and effectiveness of medical devices.

A 2001 report by the U.S. Government Accountability Office (GAO) on FDA-reviewed drug studies found 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.

A 2009 study of cardiovascular device pre-market applications showed that pivotal studies that reported sex enrolled an average of 33.9 percent 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 The draft guidance addresses study and evaluation of sex differences, data analysis and reporting in both pre- and post-market device clinical studies.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. Devices intended for single-sex use, of course, would not be expected to address potential sex differences.

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