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Sex-Specific Reporting of Scientific Research: A Workshop Summary (2012)

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

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Suggested Citation:"INCLUSION OF WOMEN IN CLINICAL TRIALS FUNDED BY THE NATIONAL INSTITUTES OF HEALTH." Institute of Medicine. 2012. Sex-Specific Reporting of Scientific Research: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13307.
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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,

Suggested Citation:"INCLUSION OF WOMEN IN CLINICAL TRIALS FUNDED BY THE NATIONAL INSTITUTES OF HEALTH." Institute of Medicine. 2012. Sex-Specific Reporting of Scientific Research: A Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13307.
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The number of women participating in clinical trials has increased during the last two decades, but women are still underrepresented in clinical trials in general. Some of the overall increase can be attributed to the greater number of women-only trials (of therapies for diseases that affect only women). Even when women are included in clinical trials, the results are often not analyzed separately by sex.

On August 30, 2011, the Institute of Medicine (IOM) Board on Population Health and Public Health Practice hosted the workshop Sex-Specific Reporting of Scientific Research. The workshop explored the need for sex-specific reporting of scientific results; potential barriers and unintended consequences of sex-specific reporting of scientific results; experiences of journals that have implemented sex-specific requirements, including the challenges and benefits of such editorial policies; and steps to facilitate the reporting of sex-specific results. Presenters and participants included current and former editors of scientific journals, researchers, and scientists and policymakers from government, industry, and nonprofit organizations. Presentations and discussions highlighted the importance to both women and men of having sex-specific data, the problems with sample size and financial constraints for conducting the research, the appropriateness of sex-specific analyses, and the limitations of journal policies to change experimental designs.

Sex-Specific Reporting of Scientific Research summarizes the presentations and discussions by the expert panelists during the IOM workshop. The workshop's first session focused on why sex-specific reporting is important. Panelists highlighted historical and current events that have hindered or helped to advance the study of women. In the next session, panelists in academe discussed the challenges of collecting, analyzing, and reporting sex-specific data from the researcher's perspective. That was followed by two panels of leading journal editors who shared their experiences in developing and implementing editorial policies and the implications of sex-specific reporting policies for journals.

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