A Brief History of Inclusion of Women in Clinical Research
Funded by the National Institutes of Health
- Late 1980s: Concerns were first raised that clinical research on conditions that affect both women and men was being conducted primarily in a homogeneous white male population but that the results were being applied in medical practice to both men and women of all races.
- 1990: ORWH was established in NIH to ensure that women are included in NIH-funded clinical studies.
- 1993: NIH policies on the inclusion of women and minorities in clinical research became law as a result of the NIH Revitalization Act of 1993 (PL 103-43). The act included four major requirements. NIH must
ensure that women and members of minority groups and their subpopulations are included in all human-subjects research;
ensure that in phase 3 clinical trials, women and minorities and their subpopulations are included in such a way that valid analyses of differences in intervention effect can be performed;
not allow cost to be used as an excuse for excluding these groups; and
initiate programs and support for outreach efforts to recruit these groups into clinical studies.
- 2000: The U.S. General Accounting Office (GAO; now the Government Accountability Office) reported that NIH had made substantial progress in strengthening and implementing its policy on inclusion of women in clinical trials.
SOURCE: Clayton, 2011.
final session, members of the workshop planning committee and others reflected on the discussion and summarized the individual suggestions made over the course of the day for advancing sex-specific reporting of scientific research.
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,