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Including Women in Clinical Research

Learning Objectives
1. Summarize how disparities in research participation impact health care and outcomes
2. Summarize the progress made and areas of improvement for the research community
3. List effective ways to increase diversity in clinical trials
0.25 Credit

Analysis of the importance of including women in research studies, the progress made, and where the research community needs to make improvement. Specifically, this article highlights the importance of including BIPOC women in studies. This issue is particularly salient for the medical community as disease and acute illness present differently across genders, a failure to include women in research impacts the quality of diagnostic tests and assessments.

Women Have Been Historically Underrepresented in Clinical Research

The historical roots of this underrepresentation can be linked back to, among other factors, a general considerations document published by the Federal Drug Administration (FDA) in 1977. The consequences of thalidomide use in pregnant women spurred new guidance on excluding women of child-bearing potential from phase 1 and phase 2 research trials. At that time researchers often assumed that women (in this context cisgender women) would have the same response to drugs as men, and viewed them as more complex and expensive participants due to fluctuating hormone levels and reproductive potential.1 The impact of these short-sighted guidelines resulted in decades-long underrepresentation of women in clinical trials research. A study published in 2019 investigated the magnitude of female underrepresentation in clinical studies performed or published between 1966 and 2018. It found that while women made up 49% of all participants enrolled during that time, they were substantially underrepresented in the majority of disease categories examined.2

This underrepresentation hindered progress on understanding women's responses to medications for decades. In 1990, the National Institutes of Health founded the Office of Research on Women's Health with a mandate to increase women's participation in research. Finally in 1993, the FDA reversed the 1977 guidance with another guidance that lifted the ban of women of child-bearing potential in early phase research. The decision to include women is now left to researchers, regulatory bodies, and women themselves.1

But female underrepresentation in clinical research persisted after the 1993 guidance until 2016. Since early 2016, women represent the majority of participants in clinical trials; male participation has been on the decline since 2017. While women now represent the majority of clinical trial participants in the US, there is still a lack of data distinguishing between cisgender women and women of the transgender experience.

Disparities in clinical trials participation

Women are especially underrepresented in clinical trials focused on cardiovascular disease, HIV, and hepatitis.2

Women in Research at Whitman-Walker Institute

Success of Whitman-Walker's research program is based on our commitment to represent the interests and diversity of patients in all projects

Research participants at Whitman-Walker are significantly more diverse than the demographic makeup of most clinical trial participants around the country, who are disproportionately non-Hispanic white men with higher education levels and household incomes4. Less than 30% of participants in clinical trials are of a racial or ethnic minority5; in contrast, 49% of Whitman-Walker's research participants are people of color. Additionally, a large number of our research participants identify as LGBTQ (70%), and 7% are transgender or gender nonconforming.

Among the women in our research program, 90.7% are women of color, 27.8% are LGBQ+, and 32.5% are trans and gender expansive. Whitman-Walker Institute sets specific study enrollment goals for transgender women to address underrepresentation of trans women in clinical trials that are important for transgender health. Eighty-four percent of the women in our studies are DC residents, and the majority of these residents live in Ward 8 (24.1%), Ward 7 (15.1%), Ward 5 (13.9%), and Ward 1 (12.5%).

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Article Information:

Copyright © 2022 Whitman-Walker Institute. All rights reserved.

Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships.

If applicable, all relevant financial relationships have been mitigated.

Liu  KA, Mager  NA.  Women's involvement in clinical trials: historical perspective and future implications.  Pharm Pract (Granada). 2016;14(1):708. doi:10.18549/PharmPract.2016.01.708Google ScholarCrossref
Feldman  S, Ammar  W, Lo  K, Trepman  E, van Zuylen  M, Etzioni  O.  Quantifying Sex Bias in Clinical Studies at Scale With Automated Data Extraction.  JAMA Netw Open. 2019;2(7):e196700. doi:10.1001/jamanetworkopen.2019.6700Google ScholarCrossref
Federal Drug Administration.  2015-2019 Drug Trials Snapshot Summary Report.  November 2020. https://www.fda.gov/media/143592/download
Loree  JM, Anand  S, Dasari  A,  et al.  Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018.  JAMA Oncol. 2019;5(10):e191870. doi:10.1001/jamaoncol.2019.1870Google ScholarCrossref
Chino  F, .  Minority participation in clinical trials: a call to action.  August 21 , 2019. https://web.archive.org/web/20201002190037/https://www.astro.org/Blog/August-2019/Minority-Participation-in-Clinical-Trials-A-Call-t

Participation Statement: Upon completion of this activity, learners will receive a Participation Certificate.


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