AL HILLIARD; SL Thompson; CA Javanmardi; M Larose-Pierre; SF Darling-Reed; JD Spates
Florida A&M University, College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health, Division of Pharmaceutical Sciences (ALH, SDR)
Florida A&M University, College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health, Division of Pharmacy Practice (SLT, CAJ, JDS, MLP)
PURPOSE: Racial and ethnic minority populations are underrepresented in clinical trial research. This is a concern because subjects of different ages, races, and ethnicities may react differently to certain medical products. The purpose of this study was to evaluate community leaders’ knowledge, beliefs, and attitudes toward racial and ethnic minority populations’ participation in COVID-19 clinical trials.
DESIGN METHODS: Focus groups consisting of 5-8 participants each were held virtually via Zoom in three Florida cities: Tallahassee, Jacksonville, and Tampa. The participants were racial and ethnic minority community leaders from social, academic, and clergy organizations. They were all asked questions that would help guide future education and training of community members to enhance participation in clinical trials. Data analysis following the transcribed verbatim recordings by trained
transcribers consisted of data organization, coding, and analysis using NVivo 14 qualitative software.
RESULTS / EXPECTED RESULTS: Nineteen participants from Tallahassee, Jacksonville, and Tampa participated in 3 focus groups. These respondents included 42% between the ages of 45-54, 58% female, and 95% Black or African American. Regardless of geographic location, most participants are still reluctant to participate in clinical trials. After analyzing NVivo 14 results, the most frequent responses dealt with clinical trial concerns, distrust, lack of knowledge and awareness of clinical
trials, and the benefits of participation. Another critical issue was trust. Historically rooted mistrust and the frequency of incorrect information shared during the pandemic caused alarm among many community leaders. A clear path to increase racial and ethnic minority participation in clinical trials is establishing a Historically Black College or University (HBCU) and community leaders’ partnership or collaboration.
DISCUSSION / CONCLUSION: Racial and ethnic minority community leaders felt more comfortable participating in clinical trials led by an HBCU. They all agreed that the relationships with the community and the credibility of HBCU faculty would enhance their willingness to participate in clinical trials.
GRANT SUPPORT
This project is supported by the Food and Drug Administration (FDA) Office of Minority Health and Health Equity of the U.S Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $707280.00 with 100 percent funded by FDA OMHHE/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.