FDA Proposal Aims to Address Women-Specific Concerns in Trials

The Food and Drug Administration (FDA) issued a draft guidance last week to address the historic underrepresentation of women in clinical studies. 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. A 2001 report by the US Government Accountability Office 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. The draft guidance addresses study and evaluation of sex differences, data analysis and reporting in both pre- and post-market device clinical studies.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. (FDA.gov)