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Policy of inclusion of women in clinical trials

In 1977, the FDA issued a guideline banning most women of "childbearing potential" from participating in clinical research studies. This was the result of certain drugs (most notably thalidomide) causing serious birth defects.1 At the time, the focus was on protecting the most vulnerable populations at all other costs.2

With the establishment of the first HHS task force on women's health in 1983, a shift away from this approach began. There was new recognition3 that many factors, including body size, hormonal environment, and even body fat distribution can affect the way drugs are metabolized.4 This could potentially mean that life-saving drugs may not work, may not work as well, or may not work similarly, in women as they do in men.5

As a result of the 1985 Report of the Public Health Service Task Force on Women's Health Issues, which encouraged reexamining current policies, NIH and the FDA both issued new guidelines to encourage more inclusion of women in studies. However, subsequent government analyses found that women were still seriously underrepresented in important studies on common diseases such as heart disease.6

In 1993, the FDA issued a new guideline and formally rescinded the 1977 policy that banned most women from participating in studies.7 To ensure that the policies for inclusion were firmly implemented by NIH, the Congress made what had previously been policy into law, through a section in the NIH Revitalization Act of 1993.8

A government report issued in 2000 concluded that NIH had made significant progress in implementing this law, and in the most recent report submitted to Congress, NIH states that substantial numbers of both women and men, and people of all different races and ethnicities, have participated in NIH research.9 But many women's health experts and advocates agree that more progress is needed. Under the 2010 Affordable Care Act, health insurance companies cannot drop or limit a person's coverage because they are participating in a clinical trial.10

Sources

  1. Merkatz, RB. (1998). Inclusion of women in clinical trials: a historical overview of scientific, ethical, and legal issues. J Obstet Gynecol Neonatal Nurs.; 27(1): 78-84
  2. McCarthy, CR. (1994). Historical background of clinical trials involving women and minorities. Acad Med; 69(9): 695-8
  3. NIH, ORWH, Inclusion of Women and Minorities in Clinical Research
  4. Schiebinger, L. (2003). Women's health and clinical trials. J Clin Invest.; 112 (7): 973–977. doi:10.1172/JCI19993
  5. Merkatz, RB. (1998). Inclusion of women in clinical trials: a historical overview of scientific, ethical, and legal issues. J Obstet Gynecol Neonatal Nurs.; 27(1): 78-84
  6. Merkatz, RB. (1998). Inclusion of women in clinical trials: a historical overview of scientific, ethical, and legal issues. J Obstet Gynecol Neonatal Nurs.; 27(1): 78-84
  7. FDA, Guidance for Industry
  8. NIH, ORWH, Inclusion of Women and Minorities in Clinical Research
  9. NIH, Comprehensive Report: Tracking of Clinical Research as Reported in Fiscal Year 2011 and Fiscal Year 2012
  10. HHS, Key Features of the Affordable Care Act By Year - 2014
All material contained on these pages are free of copyright restrictions and may be copied, reproduced, or duplicated without permission of the Office on Women’s Health in the U.S. Department of Health and Human Services. Citation of the source is appreciated.
Page last updated: April 1, 2019