FDA proposes draft guidelines intended to improve representation of women in clinical studies

Issue: January 25, 2012

The FDA recently issued draft guidance designed to address the underrepresentation of women in medical device clinical studies.

The guidance offers developers and manufacturers of medical devices recommendations for designing and conducting clinical studies that may enhance the enrollment of women.

“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 Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices,” Jeffrey Shuren, MD, director of the FDA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, said in a press release.

Certain medical products may elicit different responses in women than in men. This may be due in part to genetics, hormones, body size, diet or sociocultural issues. In addition, certain variables associated with women — such as size or certain illnesses — may be responsible for certain differences in the safety and effectiveness of medical devices between genders.

A 2011 report by the US Government Accountability Office on FDA-reviewed drug studies found that, although women represented 52% of study enrollees, 30% of study documents did not report outcomes by gender and nearly 40% did not report enrollment demographics.

The draft guidance addresses study and evaluation of gender differences, data analysis and reporting in both pre- and post-market device clinical studies. In addition, it covers issues regarding statistical analyses of gender differences and how to report gender-specific information in summaries and labeling for approved devices.

The FDA will accept input on the draft guidance during a public comment period that will continue through mid-March.

For more information:

The draft guidance can be found at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm.