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Doruntina Fida, MPH
Pronouns
She/her
Rank
Research Staff
Institution
Brigham and Women's Hospital
Department
Psychiatry & the Connors-BRI Center for Women's Health and Gender Biology
Authors
Doruntina Fida1, Ruth Lederman 2, Julie Wilson1, Aleta Wiley1, Primavera A. Spagnolo1,3 1: Department of Psychiatry & Connors Center for Women’s Health and Gender Biology, Brigham and Women’s Hospital, Boston, MA 2: Survey and Data Management Core, Dana Farber Cancer Institute, Boston, MA 3: Harvard Medical School, Boston, MA
Principal Investigator
Categories:
Background: Despite some progresses, women remain underrepresented in clinical trials (CT) in multiple therapeutic areas. Here, we surveyed a large cohort of U.S. women to determine their attitudes toward clinical research and assess barriers and resources to CT participation.
Methods: Women aged 18-65 residing in the U.S. were recruited via an online platform. Following consent, they completed a survey including 81 questions, which assessed four domains: demographics; health status; access to health-related information and healthcare services; and CT attitudes and participation. This latest domain was assessed using the Clinical Trials Attitudes scale as well as self-developed questions validated using cognitive interviews.
Results: A total of 5,301 women completed the survey from January 2023 to May 2023. Of those, 71% were White, 13% were Black, 1.1% were Hispanic/Latina, and 6.8% were Asian. The average age of the participants was 38.3 years (±13.6). 356 women (7.2%) in our sample reported to have previously participated in a CT. Among those who did not participate, 23% expressed interest in enrolling in clinical studies. The top 3 motivating factors to enroll were: availability of detailed information on the trial, compensation, and benefiting other women. Specifically, 62% of women reported awareness of sex-differences in biology as a critical motivating factor. The top 3 helpful resources were: clear explanation of potential impact on one’s health, study materials available in one’s native language, and use of multimodal approaches to explain the trial. Conversely, women in our cohort reported that the top 3 factors preventing participation in CT were: the risk of unknown side effects, time commitment, and distrust of doctors.
Conclusions: To our knowledge, this is the first study assessing attitudes to CT participation in a large cohort of women. Our findings clearly indicate specific strategies that can be implemented to improve women’s representation in clinical studies.
