Identification of Barriers to and Practical Strategies for Increasing Clinical Trial Diversity: A Scoping Review
Author(s)
Dominique Seo, MPH1, Divya Patil, MS, Other2, Jennifer Choi, PhD3, Emily Gorman, MLIS4, Abdou S. Senghor, PhD2, T. Joseph Mattingly II, MBA, PharmD, PhD5;
1University of Maryland, Baltimore, Graduate Student, Baltimore, MD, USA, 2University of Maryland, Baltimore, Baltimore, MD, USA, 3Uniersity of Maryland, Baltimore, Baltimore, MD, USA, 4Health Sciences and Human Services Library, University of Maryland, Baltimore, Baltimore, MD, USA, 5University of Utah, Pharmacotherapy, Salt Lake City, UT, USA
1University of Maryland, Baltimore, Graduate Student, Baltimore, MD, USA, 2University of Maryland, Baltimore, Baltimore, MD, USA, 3Uniersity of Maryland, Baltimore, Baltimore, MD, USA, 4Health Sciences and Human Services Library, University of Maryland, Baltimore, Baltimore, MD, USA, 5University of Utah, Pharmacotherapy, Salt Lake City, UT, USA
Presentation Documents
OBJECTIVES: The US Food and Drug Administration has an increased emphasis on the importance of diversity in clinical trials. Historically, clinical trials have focused on white males, excluding minorities, women, older adults, children, and those with multiple health conditions. Inclusion of diverse populations is vital for quality science, result generalizability, safety understanding, equity promotion, and tailored intervention identification. This scoping review aims to identify practical strategies and resources to overcome persistent barriers to increasing clinical trial diversity, thereby promoting equity in clinical trial protocol development, recruitment, and implementation.
METHODS: A systematic search was conducted in Embase, Medline, and Cochrane Library to identify tools for facilitating equity-focused protocol design in COVID-19 clinical trials. Studies were included if they were in English and discussed tools or interventions to increase clinical trial diversity. Discrepancies were resolved through consensus. Data were extracted on a variety of variables, including study type, location, population description, and details of the tools used. A quantitative review categorized included articles, and a qualitative thematic analysis identified trial design and implementation practices or tools to enhance diversity.
RESULTS: A total of 79 papers were included. We identified four key themes on clinical trial diversity: barriers, participation promotion activities, outcomes, and resources. Barriers exist at patient- and provider-levels. Strategies to mitigate barriers include building community trust, improving communication, instituting institutional changes, and implementing specific interventions. Resources to enhance participation include financial support, cultural competency training, technology utilization. Outcomes underscore the significance of community engagement and role of resources in boosting trial recruitment.
CONCLUSIONS: We identified patient and provider-level barriers to clinical trial diversity and tools to enhance equity. This review emphasizes a need for greater attention on recruiting underrepresented patient populations. Furthermore, this underscores the need for development and use of tools tailored for assessing and effectively disseminating clinical trial results.
METHODS: A systematic search was conducted in Embase, Medline, and Cochrane Library to identify tools for facilitating equity-focused protocol design in COVID-19 clinical trials. Studies were included if they were in English and discussed tools or interventions to increase clinical trial diversity. Discrepancies were resolved through consensus. Data were extracted on a variety of variables, including study type, location, population description, and details of the tools used. A quantitative review categorized included articles, and a qualitative thematic analysis identified trial design and implementation practices or tools to enhance diversity.
RESULTS: A total of 79 papers were included. We identified four key themes on clinical trial diversity: barriers, participation promotion activities, outcomes, and resources. Barriers exist at patient- and provider-levels. Strategies to mitigate barriers include building community trust, improving communication, instituting institutional changes, and implementing specific interventions. Resources to enhance participation include financial support, cultural competency training, technology utilization. Outcomes underscore the significance of community engagement and role of resources in boosting trial recruitment.
CONCLUSIONS: We identified patient and provider-level barriers to clinical trial diversity and tools to enhance equity. This review emphasizes a need for greater attention on recruiting underrepresented patient populations. Furthermore, this underscores the need for development and use of tools tailored for assessing and effectively disseminating clinical trial results.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HSD31
Topic
Health Service Delivery & Process of Care
Disease
No Additional Disease & Conditions/Specialized Treatment Areas