BOX 1
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

inline  ensure that women and members of minority groups and their subpopulations are included in all human-subjects research;

inline  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;

inline  not allow cost to be used as an excuse for excluding these groups; and

inline  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.

INCLUSION OF WOMEN IN CLINICAL TRIALS FUNDED BY
THE NATIONAL INSTITUTES OF HEALTH

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,



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4 SEX-SPECIFIC REPORTING OF SCIENTIFIC RESEARCH BOX 1 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 condi- tions 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 includ- ed 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 minori- ties 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 re- cruit 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. INCLUSION OF WOMEN IN CLINICAL TRIALS FUNDED BY THE NATIONAL INSTITUTES OF HEALTH 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,