Pursuant to a congressional request, GAO provided information on the National Institutes of Health's (NIH) efforts to include women in clinical research, focusing on: (1) the extent to which women are being included in clinical research that NIH funds; (2) the activities and accomplishments of the NIH Office of Research on Women's Health (ORWH) in promoting women's health research at NIH; and (3) how much funding NIH has allocated to research on health issues that affect women.
Recommendations for Executive Action
|National Institutes of Health||To strengthen the capacity of biomedical research to produce information on health applicable to all segments of the population, the Director, NIH, should ensure that the agency implements the requirement that phase III clinical trials be designed and carried out to allow for the valid analysis of differences between women and men as fully as it implements other elements of the inclusion policy. Specifically, NIH should appropriately communicate this requirement to applicants, that peer review groups explicitly determine whether each proposed phase III clinical trial is required to have such a study design, and that summary statements document the initial reviewers' decisions.|
|National Institutes of Health||To improve the accuracy of NIH's tracking data on the inclusion of women and minorities, the Director, NIH, should ensure that NIH staff who transmit data to the tracking system receive ongoing training on the requirements and purpose of the system.|