Draft guidance aimed to address the historic underrepresentation of
women in clinical studies was issued by the U.S. Food and Drug
Administration today. 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 “Our draft guidance outlines what we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draft guidance addresses study and evaluation of sex differences, data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.
The FDA is seeking input on this draft guidance during a 90 day public comment period. The draft guidance can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm283453.htm.
