On behalf of the workshop sponsor and as background for the discussions, Janine Clayton, deputy director of ORWH, provided a brief history of the inclusion of women in NIH-funded clinical studies (Box 1). Despite the success of NIH efforts to enhance enrollment of women, the law and policy apply only to NIH-funded studies, not to studies done by or supported by other agencies or entities. In addition, NIH cannot require editors and journals to mandate inclusion of analysis by sex in reports of studies. As a result, key health data are not reaching other researchers and the public.
To begin to address that situation, ORWH established a working group of scientific-journal editors as an ad hoc subgroup of the Advisory Committee on Research on Women’s Health. In 2001, the group issued a statement calling on scientific journals to require that, where appropriate, clinical and epidemiologic studies be analyzed to see whether there is an effect of sex; if there is no effect, that should also be reported. Any statistical limitations of such analyses should be made clear. To date, however, very few journals have adopted such a policy. Clayton cited the Journal of the National Cancer Institute (JNCI) as an example of journals that address sex-specific analysis in their instructions for authors.
The continuing challenge, Clayton concluded, is to get sex-differences research accomplished and the results reported, from basic through applied research.
National Academies Press (US), Washington (DC)
Institute of Medicine (US) Board on Population Health and Public Health Practice. Sex-Specific Reporting of Scientific Research: A Workshop Summary. Washington (DC): National Academies Press (US); 2012. INCLUSION OF WOMEN IN CLINICAL TRIALS FUNDED BY THE NATIONAL INSTITUTES OF HEALTH.