GAO releases report on women in clinical trials
The General Accounting Office (GAO) released a report stating that "FDA has not effectively overseen the presentation and analysis of data related to sex differences in drug development." Thus, the GAO recommended that FDA implement new management tools, including a demographic worksheet and template for medical officer reviews, to enforce data presentation regulations.
The study investigated FDA's progress in addressing the inclusion of women in clinical trials since the release of a 1992 GAO report stating that the agency did not ensure female representation or study sex differences in clinical trials. According to the new GAO report, about 33% and 39% of NDAs and INDs, respectively, do not meet data presentation requirements of a 1998 FDA regulation requiring that safety and efficacy data be presented separately for men and women. ...