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Background on Clinical Trials Legislation

In 1985, the U.S. Public Health Service Task Force on Women’s Health Issues concluded that lack of representation of women in research compromised the quality of the health care they receive. This finding prompted the National Institutes of Health (NIH) to announce a policy recommending the inclusion of women in federally funded clinical research. In 1990, at the urging of the Society for Women’s Health Research, Congress ordered the GAO to conduct a study into NIH’s policies and practices regarding the inclusion of women. The U.S. General Accounting Office (GAO) report disclosed a lack of improvement in the inclusion of women in NIH-funded research.   Specifically, NIH policy on the inclusion of women in clinical trials had not been well communicated or understood within NIH or the research community, was applied inconsistently across institutes, and was only applied to extramural research.   

In response to the GAO findings, SWHR in cooperation with the Congressional Caucus on Women’s Issues introduced the Women’s Health Equity Act. The bill contained language to create an office specifically devoted to women’s health research at NIH and to require that women be included in NIH-funded clinical trials.   While the legislation was unsuccessful, it was the motivation behind NIH creating the Office of Research on Women’s Health (ORWH) to coordinate women’s health research activities across the NIH institutes and centers. Furthermore, NIH instituted guidelines for grant submissions, which required the inclusion of women in research.

In 1993, the NIH Revitalization Act was passed by Congress and signed into law. This legislation made ORWH permanent, included guidelines to ensure that women are included in NIH research, and required the analysis of resulting data by sex.   Requiring women to be included was a major shift in biomedical research. Scientists could no longer categorically deny women access to clinical trials; instead they had to provide a scientific argument to justify women’s exclusion.

At the same time, a report on the practices of the Food and Drug Administration (FDA) in approving prescription drugs was released in 1992. The report found that while women were sometimes included in drug trials, they were underrepresented (GAO, Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing). Even when women were included in large numbers, data were not analyzed to determine if women’s responses differed from those of men.   The report recommended that the FDA should ensure that drug companies consistently include sufficient numbers of women in drug testing to identify gender-related differences in drug responses so that such differences are explored and studied. As a result of the report, the FDA lifted its restriction regarding the inclusion of women of childbearing potential in clinical trials and formalized guidelines regarding the analysis of data by sex.  

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