Studies released last month show that although the National Institutes of Health (NIH) has been slow to enforce guidelines from its 1993 NIH Revitalization Act, regarding the enrollment of women in clinical trials and the analysis of trial data by gender, it has made progress in this area.

In a paper to be published this month in the Journal of Women's Health and Gender-based Medicine, the authors surveyed scientific literature from four major medical journals—New England Journal of Medicine, the Journal of the American Medical Association, the Journal of the National Cancer Institute, and Circulation— for the years 1993, 1995, 1997 and 1998. They found that approximately one-fifth of the NIH-funded studies published each year failed to include women as research subjects, and only one-third of the studies that did include women analyzed data by sex of the subjects.

However, because clinical trials can take several years from enrollment to completion, this research includes data from studies that would have been initiated before the revitalization act. In fact, an audit of the NIH's clinical research studies during FY97 by the General Accounting Office (GAO) does show improvement—more than half of trial participants were women in that year. Specifically, data for all extramural research protocols funded, which were tracked by the NIH, show that 61.9% of subjects were women and looking at Phase III studies reveals that only 74.8% were woman. The report concludes, “In the past decade, NIH has made significant progress in implementing a strengthened policy on including women in clinical research.” These 1997 figures should begin to show up in studies published in the literature this year.

But the news is not all good. The GAO was less flattering about the NIH's implementation of the requirement that trials be designed to permit valid analysis by gender, which can reveal whether interventions affect the sexes differently. It found that the NIH had not adequately enforced this policy and recommends that the director of the NIH ensure 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.”

This is the second time that the GAO has examined the NIH's inclusion of women in trials. In 1990 it found that the agency had not acted on guidelines it had set in 1986 urging the inclusion of women of child-bearing age in federally funded trials. This led to the 1990 establishment of the NIH Office of Research on Women's Health (ORWH), whose responsibility it is to ensure that women and minorities are included in studies. The ORWH's budget has increased from $9.4 million in 1993 to around $20 million in FY00, and this office is now preparing a report on its 1997–1998 activities for the director of the NIH.

The new GAO report was commissioned by senators Tom Harkin (D-IA), Olympia Snowe (R-ME) and Barbara Mikulski (D-MD), who are now asking Senator Jim Jeffords (R-VT), chairman of the Committee on Health, Education, Labor and Pensions, to debate the subject in congress. They have also requested that by the year's end the GAO carries out a similar assessment, through the Food and Drug Administration, of the number of women in trials sponsored by the pharmaceutical industry.