Understanding barriers to clinical trial participation among U.S. women: a national survey study

Women—particularly those from racially and ethnically minoritized groups—remain underrepresented in clinical research, yet their perspectives on participation are not well characterized. We conducted a national cross-sectional online survey of 5,301 U.S. women aged 18–70 years to assess willingness to participate (WTP), experiences with clinical trials, and awareness of sex-based differences in relation to research engagement. Because participation is shaped by social and structural determinants, we examined racial differences alongside socioeconomic status, healthcare access, and self-reported health to delineate intersecting contributors to disparities.

Among 4,987 respondents reporting race (77% White, 14% Black, 7% Asian, 2% Other), most expressed at least tentative interest in participating (23% “definitely”, 60% “maybe”), yet only 11% had ever been invited and 7% had enrolled. In adjusted models, WTP was lower among Black women (β=−0.4; P = 0.0003) than among White women, whereas higher educational attainment and multimorbidity predicted greater WTP. Preferred resources, motivators, and perceived barriers also differed by race, which may inform tailored engagement strategies.

Finally, most respondents (88%) endorsed women’s inclusion and sex-specific reporting in clinical research, suggesting that emphasizing the sex-specific relevance of research merits evaluation as an engagement strategy. Our findings suggest that limited invitation, together with structural and informational barriers, may contribute to women’s low participation, and support the evaluation of trust-building, burden-reducing, and culturally responsive strategies centered on women’s needs and perspectives to improve equitable representation. This work was supported by the Connors Center for Women’s Health Research Casey Toolin McAuliffe Memorial IGNITE Award, Brigham and Women’s Hospital, Boston, MA, USA.The research team would like to thank Anna Joseph for her help in data collection.

We would also like to thank the Survey and Data Management Core at Dana-Farber Cancer Institute, and specifically Brett Nava-Coulter for his help with cognitive interviewing, and Michelle Fredericks for her help with the statistical analysis. Connors Center for Women’s Health Research, Brigham and Women’s Hospital, Boston, MA, USA Doruntina Fida, Therese A. Rajasekera, Aleta Wiley & Primavera A.

Spagnolo Department of Psychiatry, Brigham and Women’s Hospital, Boston, MA, USA Doruntina Fida, Aleta Wiley & Primavera A. Rajasekera & Primavera A. Spagnolo University of Massachusetts Chan Medical School, Worcester, MA, USA Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA Survey and Data Management Core, Dana Farber Cancer Institute, Boston, MA, USA Department of Psychiatry, Brigham and Women’s Hospital, Mary Horrigan Connors Center for Women’s Health Research, Harvard Medical School, Thorn Building, 75 Francis Street, Boston, MA, USA Correspondence to Primavera A.

PAS reported receiving honoraria from Walgreens and from the American College of Neuropsychopharmacology for presentations outside of the current work. The other authors have no competing interests to report. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.