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Understanding Barriers to Clinical Trial Participation Among U.S. Women: A National Survey Study

Fida, D.; Rajasekera, T. A.; Roy, A.; Wilson, J. C.; Wiley, A.; Lederman, R.; Spagnolo, P. A.

2025-10-28 public and global health
10.1101/2025.10.28.25337741 medRxiv
Show abstract

Despite the persistent underrepresentation of women--particularly those from racially and ethnically minoritized groups--in clinical research, little is known about their perspectives on participation. This study examined healthcare experiences, access, and attitudes toward clinical trials among U.S. women and assessed how race, socioeconomic status, and healthcare access intersect to shape willingness to participate (WTP). We conducted a national cross-sectional online survey (January-March 2023) of 5,301 women aged 18-70 years. The 81-item questionnaire assessed demographics, health status, healthcare access, and clinical trial experiences. Among 4,987 respondents reporting race (77% White, 14% Black, 7% Asian, 2% Other), nearly 80% expressed interest in participating in clinical trials, yet only 11% had been invited and 7% had enrolled. In adjusted models, WTP was lower among Black ({beta} = -0.06; P = .04) and Asian ({beta} = -0.09; P = .01) women than among White women, whereas higher educational attainment and multimorbidity predicted greater WTP. Altruism, clear study explanations, and financial compensation were key motivators, while time burden and concerns about side effects were major barriers, with the salience of these factors varying by race. Most respondents (88%) endorsed the importance of womens inclusion and sex-specific reporting, though neutrality on these issues was more frequent among racially minoritized women. Despite high interest, structural and informational barriers continue to constrain womens engagement in clinical research, underscoring the need for trust-building, burden-reducing, and culturally responsive strategies to promote equitable participation and improve representation across racial groups.

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