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Gap in Understanding Women's Health

Writer's picture: Anastacia DrakeAnastacia Drake

Prior to 1993, women were seldom part of clinical trials. Even today, the medical community remains uncertain about the effectiveness of many drugs and devices for women.


Historically, women have been excluded from clinical trials, leading to a significant knowledge gap in understanding how diseases affect women. Policies and ongoing challenges to recruiting and retaining women in clinical trials and medical research resulted in women’s bodies being seen as "atypical," with male physiology considered the “norm.” This has led to women experiencing adverse effects from medications at twice the rate of men and receiving inadequate treatment for conditions like heart disease



  • 1962: After thalidomide, a medication sometimes used for morning sickness in Europe and Australia, results in more than 10,000 deaths and birth defects in babies, the United States strengthens the authority of the FDA.

  • 1977: The FDA creates a guideline to exclude women of reproductive potential from participating in early phase clinical research, except for life-threatening conditions. This is broadly applied and essentially excludes most women of childbearing age from medical research.

  • 1986: An NIH advisory committee recommends that women be included in medical research studies.

  • 1990: The NIH establishes the Office of Research on Women’s Health, which leads a variety of programs aimed at advancing research into women’s health and increasing representation of women as both participants and investigators in clinical research.

  • 1991: Bernadine Healy, MD, is appointed the first female director of the NIH.

  • 1993: The FDA reverses its 1977 guidance, officially mandating the inclusion of women in research unless there is a justification for exclusion (for example, if the disease only affects men).

  • 1993: The U.S. Congress passes a law requiring inclusion of women in NIH-sponsored clinical trials.

  • 1994: The FDA establishes the Office of Women’s Health, which is charged with promoting the inclusion of women in clinical trials and the advancement of women’s health care.

  • 2001: The Institute of Medicine releases a report that demonstrates how sex difference influences biology and should be studied as a variable in clinical research.

  • 2022: A Harvard Medical School study finds that women, as of 2019, were still substantially underrepresented in clinical trials for leading diseases.


Even today, women remain underrepresented in clinical trials. A 2022 study found women made up only 40% of participants in trials for diseases that disproportionately affect women. This is compounded by the fact that pregnant women are often excluded from research, leaving doctors with little information on the effects of medications during pregnancy. Women of color face even greater challenges, with significant underrepresentation in clinical trials and health data that fail to report the intersection of biological sex and race.


This may contribute to health care disparities, as biological sex can play a role in physiological, metabolic, hormonal, and even cellular differences that can influence how diseases present and the effectiveness of pharmaceuticals and medical devices.

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