Women's Health

The National Institutes of Health (NIH) has made significant progress toward the goal of including women and minorities in research. For the policy to have its intended effect, however, NIH needs to expand its focus beyond simple inclusion and to ensure that, when it is scientifically appropriate, researchers conducting clinical trials enroll populations and analyze study data in ways that enable them to learn whether interventions affect women and men differently. NIH staff, peer reviewers, and advisory council members should carry out this dimension of the inclusion policy as conscientiously as they attend to its other components. For example, when NIH initiates a phase III clinical trial through a request for application or proposal, unless NIH officials have determined that this particular trial is exempt from the requirement, the request should inform the applicants that they should design the trial to allow for a valid analysis of differences between women and men. As reviewers examine each application to receive funding for a phase III clinical trial, they need to explicitly consider whether the study should be structured to allow for analysis by sex. Also, NIH's tracking system is an important tool for monitoring the implementation of the inclusion policy, and the system is beginning to capture more information, such as enrollment targets, that will help assess the policy's success. NIH's recent steps to improve the system and move toward increased electronic reporting should help improve the accuracy and the timeliness of the data and improve the system's ability to measure progress. However, follow-up training on the requirements and the purpose of the tracking system is needed. Finally, NIH's data on spending on women's health must be interpreted with care. Determining which expenditures affect women's health is so complex and imprecise that it is easy to overstate or understate the extent of NIH's efforts. The nature of scientific inquiry makes it impossible to predict all the effects of research, and this is especially true for the basic research that makes up a large part of NIH's portfolio.

GAO noted that: (1) NIH has made significant progress in implementing a strengthened policy on including women in clinical research; (2) NIH issued guidelines to implement the 1993 NIH Revitalization Act and conducted extensive training for scientists and reviewers; (3) the review process for extramural research now treats the inclusion of women and minorities as a matter of scientific merit, which affects a proposal's eligibility for funding, and it appears that NIH staff and researchers are working to ensure that, when appropriate, study findings will apply to both women and men; (4) NIH implemented a centralized inclusion tracking data system that is an important tool for monitoring the implementation of the inclusion policy; (5) NIH has made less progress in implementing the requirement that certain clinical trials be designed and carried out to permit valid analysis by sex, which could reveal whether interventions affect women and men differently; (6) more than 50 percent of the participants in clinical research studies that NIH funded in fiscal year (FY) 1997 were women, according to NIH; (7) minority women were well represented, especially black and Asian and Pacific Islander women, however, the proportion of Hispanic women enrolled was below their proportion in the general population; (8) ORWH has lead responsibility for ensuring that women and minorities are included in clinical research that NIH funds; (9) its budget grew from $9.4 million in FY 1993 to about $20 million in FY 2000; (10) ORWH uses its budget to leverage increased funding for research on women's health by the institutes and centers; (11) it has carried out extensive training and education on the inclusion policy for staff members, investigators, and institutional review boards; (12) however, ORWH has not conducted updated training on the data tracking system to ensure that its data are accurate and consistent; (13) NIH annually reports how much it spends on women's health, men's health, and conditions that affect both women and men; (14) however, the nature of scientific inquiry makes it impossible to predict how research will affect specific populations, especially with regard to the basic research that receives a substantial portion of NIH resources, and GAO found inconsistencies in the methods NIH staff use to produce its expenditure estimates; (15) according to NIH, spending on women's health conditions grew by 39 percent between fiscal years 1993 and 1999; and (16) NIH's total spending on diseases and conditions unique to or more prevalent in women grew more rapidly than NIH's overall spending from FY 1993 to FY 1999.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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