Since 1984, when the U.S. Department of Health & Human Services (HHS) Coordinating Committee on Women’s Health (CCWH) was established, women’s health in the United States has improved by leaps and bounds. According to the HHS, areas of progress include:1

  • Improved access to health care
  • New health programs for women
  • Development or funding of new treatments and screening techniques
  • Key policy changes
  • Approved life-saving vaccines
  • Publishing of landmark reports

While these are good news stories, increasing women’s participation in clinical studies has been more of an uphill battle. Let’s look at the backstory.

Women in clinical trials—1977 to today

In response to a surge of serious birth defects from drugs such as thalidomide, the Food and Drug Administration (FDA) in 1977 “banned most women of ‘childbearing potential’ from participating in clinical research studies.”2 Although seemingly harsh, this measure was seen at the time as the best way to protect unborn children from the potential harmful effects of drugs.

By the 1980s, it became clear that many drugs are metabolized differently in women than men.3 As a result, it was found that many life-saving drugs might not perform or perform in the same way as they do for men.4 

In response, the National Institutes of Health (NIH) and the FDA both put out new guidelines in 1985 to encourage more inclusion of women in clinical trials. Subsequent government studies found that women were still underrepresented in clinical trials.5

In 1993, the FDA revoked the 1977 policy that prohibited most women from joining studies.6 By 2000, the government reported improvement in inclusion of women in studies, and a recent report stated that “substantial numbers of both women and men, and people of all different races and ethnicities, have participated in NIH research.”7 However, health advocates point out that more work is needed to ensure women (and minorities) are accurately represented in clinical studies.

A recent study backs this assertion. It looks at the participation of women in trials focused on investigational drugs and devices. The data came from Clinicaltrials.gov and covered 1,433 Phase 1-3 studies performed over a four-year period (2016-2019). Of the 302,664 participants, on average, 41.2% were female. Females were also underrepresented compared with their proportion of the disease population as shown in the chart below:8

Trial Focus % of Female Trial Participants % of Disease Population = Female
Cardiovascular disease 41.9% 49%
Psychiatry 42.0% 60%
Cancer 41.0% 51%

These gaps between trial participant numbers and gender representation in the disease populations call for continued emphasis on increasing the inclusion of women in trials, especially “given potential sex-based differences in treatment responses and toxicities.”9

In considering ways to increase the participation of women in clinical trials, it’s important to consider time and cost, especially for women of childbearing age. According the NIH and HHS, successful strategies include:10

  • Offering extended and flexible clinic hours
  • Providing at-home follow-up for participants
  • Offering childcare and transportation, or reimbursing participants for these services
  • Reimbursing study participants for their time and possible discomfort. 

In addition, 83bar supports the use of decentralized trials to improve the participation of women and other underrepresented populations. These trials allow participants to take part in their homes or at nearby clinics, saving participants time and money and helping them to feel more relaxed about the process.

83bar is committed to helping women and minorities gain equal access to clinical trials. To learn more about issues surrounding health care and participation in clinical  research from a patient viewpoint, review the findings of our recent survey in the report titled the Patient Pulse.

You can also see how 83bar works to help increase diversity in clinical research by reading Combating Racial Disparities in Health Care or scheduling a meeting with our experts.

Sources:

  1. Department of Health and Human Services (US), Office on Women’s Health. 30 achievements in women’s health in 30 years (1984–2014) [cited 2014 Jun 25] Available from: URL: http://womenshealth.gov/about-us/government-in-action/achievements.
  2. 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
  3. Schiebinger, L. (2003). Women’s health and clinical trials. J Clin Invest.; 112 (7): 973–977. doi:10.1172/JCI19993
  4. 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
  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. FDA, Guidance for Industry
  7. NIH, Comprehensive Report: Tracking of Clinical Research as Reported in Fiscal Year 2011 and Fiscal Year 2012
  8. Alexandra Z. Sosinsky, Janet W. Rich-Edwards, Aleta Wiley, Kalifa Wright, Primavera A. Spagnolo, Hadine Joffe, Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019, Contemporary Clinical Trials, Volume 115, 2022, 106718, ISSN 1551-7144, https://doi.org/10.1016/j.cct.2022.106718.
  9. Alexandra Z. Sosinsky, Janet W. Rich-Edwards, Aleta Wiley, Kalifa Wright, Primavera A. Spagnolo, Hadine Joffe, Enrollment of female participants in United States drug and device phase 1–3 clinical trials between 2016 and 2019, Contemporary Clinical Trials, Volume 115, 2022, 106718, ISSN 1551-7144, https://doi.org/10.1016/j.cct.2022.106718.
  10. NIH and HHS, Successfully Including Women in Clinical Trials, pamphlet, 2011