The FDA Focuses on Women In Clinical Trials

In July of 2001, the GAO issued a Congressional Report that found that drug manufacturers often failed to meet 1998 data presentation requirements regarding safety and efficacy data by sex. The report recommended that among other things the FDA:

…implement management tools, such as the proposed demographic worksheet and the standardized template for the medical officers’ reviews, that will allow it to enforce current regulations about the presentation of data for women in clinical drug trials and to ensure that its reviewers consistently and systematically document and discuss sex differences in their written reviews of new drug applications.

Citing the 2001 GAO report, on December 16, 2011, the FDA announced the issuance of a draft guidance that addresses study and evaluation of sex differences, data analysis and reporting in both pre- and post-market device clinical studies. It also covers issues regarding statistical analyses of sex differences and how to report sex-specific information in summaries and labeling for approved devices.

The draft guidance provides recommendations for achieving a representative enrollment, study designs for both new and ongoing studies as well as completed studies and postmarket studies. It remains to be seen what, if else, the FDA has planned for the device market, but suffice to say there appears to be movement on the regulation side.