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. 2023 Feb 16;18(2):e0281940.
doi: 10.1371/journal.pone.0281940. eCollection 2023.

Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions-A report from the "Health Equity through Diversity" seminar series

Affiliations

Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions-A report from the "Health Equity through Diversity" seminar series

Luiza Reopell et al. PLoS One. .

Abstract

Introduction: In recent years, there has been increasing awareness of the lack of diversity among clinical trial participants. Equitable representation is key when testing novel therapeutic and non-therapeutic interventions to ensure safety and efficacy across populations. Unfortunately, in the United States (US), racial and ethnic minority populations continue to be underrepresented in clinical trials compared to their White counterparts.

Methods: Two webinars in a four-part series, titled "Health Equity through Diversity," were held to discuss solutions for advancing health equity through diversifying clinical trials and addressing medical mistrust in communities. Each webinar was 1.5 hours long, beginning with panelist discussions followed by breakout rooms where moderators led discussions related to health equity and scribes recorded each room's conversations. The diverse groups of panelists included community members, civic representatives, clinician-scientists, and biopharmaceutical representatives. Scribe notes from discussions were collected and thematically analyzed to uncover the central themes.

Results: The first two webinars were attended by 242 and 205 individuals, respectively. The attendees represented 25 US states, four countries outside the US, and shared various backgrounds including community members, clinician/researchers, government organizations, biotechnology/biopharmaceutical professionals, and others. Barriers to clinical trial participation are broadly grouped into the themes of access, awareness, discrimination and racism, and workforce diversity. Participants noted that innovative, community-engaged, co-designed solutions are essential.

Conclusions: Despite racial and ethnic minority groups making up nearly half of the US population, underrepresentation in clinical trials remains a critical challenge. The community engaged co-developed solutions detailed in this report to address access, awareness, discrimination and racism, and workforce diversity are critical to advancing clinical trial diversity.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Barriers and solutions to clinical trial participation.
This figure displays the four major themes explored in this paper and the barriers and solutions associated with each theme.

References

    1. Gray DM, Nolan TS, Gregory J, Joseph JJ. Diversity in clinical trials: an opportunity and imperative for community engagement. The Lancet Gastroenterology & Hepatology. 2021. Aug;6(8):605–7. doi: 10.1016/S2468-1253(21)00228-4 - DOI - PubMed
    1. Agodoa L, Alanis AJ, Alexander-Bridges M, Bitow N, Doan LL, Fleming GA, et al.. The Endocrine Society’s Task Force on Increasing Minority Participation in Clinical Research. 2007;36. - PubMed
    1. U.S. Food & Drug Administration. 2015–2019 Drug Trials Snapshots Summary Report—Five-Year Summary and Analysis of Clinical Trial Participation and Demographics [Internet]. Washington (DC): U.S. Food & Drug Administration; 2020. Nov [cited 2021 Jul 19]. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snaps...
    1. Regnante JM, Richie NA, Fashoyin-Aje L, Vichnin M, Ford M, Roy UB, et al.. US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials. JOP. 2019. Apr;15(4):e289–99. doi: 10.1200/JOP.18.00638 - DOI - PubMed
    1. Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, et al.. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol. 2019. May;44(5):148–72. doi: 10.1016/j.cpcardiol.2018.11.002 - DOI - PubMed

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