Abstract

Identifying barriers and facilitators to increase diversity in clinical trials

Emilie Ruiz, BS1, Meera Patel, PhD1, Heather Kitzman, PhD2, Eunice Huan, BS1, Zahria Griggs, BS1 and Ketan Tamirisa1
(1)University of Texas Southwestern Medical Center, Peter J. O’Donnell Jr. School of Public Health, Dallas, TX, (2)University of Texas Southwestern Medical Center, Dallas, TX

APHA 2024 Annual Meeting and Expo

Clinical trials provide evidence-based findings to establish the safety and efficacy of novel medications and treatments. Research shows that many factors, such as race/ethnicity, sex, age, and genetics, drive differential responses to therapeutics and disease outcomes. According to the 2020 Drug Trials Snapshots Summary Report (FDA), approximately 75% of research participants were White underscoring the underrepresentation of racial/ethnic minority populations impeding the development of effective treatments for this population. The primary objective of our qualitative study is to improve access and enrollment in clinical research in low-income, racial/ethnic minority communities by understanding facilitators and barriers to participation. Focus groups (n=4) were conducted with primarily Black and Hispanic persons from urban communities experiencing poverty. Focus group questions and a corresponding codebook was developed using The Social Ecological Model and focus group data was analyzed using Directed Content Analysis by three racially/ethnically diverse research staff. Through consensus, staff reached 100% agreeability on coded transcript themes. Focus group participants (n=51) had a mean (SD) age of 59.6 (15.1) years, 92.2% female, 47% Hispanic, 53% African American, primarily high school education, and income between $20,000-≤ 35,000. Primary themes identified as barriers included fear of research (individual), beliefs/myths/misconceptions of research (interpersonal), historical experiences (community), and high frequency of medical mistrust (macro/policy). Themes identified as facilitators included receiving personal health knowledge (individual), trusted relationships (interpersonal), community health (community), transparency regarding safety and risk (macro/policy). Primary themes identified as strategies for implementation included increasing self-accountability (individual), identifying with research staff/individual (interpersonal), awareness of research (community), and building lasting relationships with community (macro/policy). From these results, we will inform a series of co-learning sessions to inform the development of practical tools for researchers and community stakeholders to increase trust, improve knowledge, and provide researcher tools on how to increase diversity in clinical research. To improve health disparities in chronic disease, strategies developed through community and stakeholder input are required to effectively increase diversity in clinical research nationally.

Assessment of individual and community needs for health education Diversity and culture Implementation of health education strategies, interventions and programs Public health or related education Public health or related public policy Public health or related research