A  ALI; S Suther; T Lee; J Spates

Florida A&M University, College of Pharmacy and Pharmaceutical Sciences, Institute of Public Health (AA, SS, JS); Tuskegee University, Department of Graduate Public Health (TL)

PURPOSE

The rapid development of pharmaceutical treatments and vaccines brought clinical trial participation to the forefront during the COVID-19 pandemic. The purpose of this research was to assess community perceptions of clinical trials and to learn strategies to increase participation in clinical trials among racial and ethnic minorities communities.

METHODS

Between November 2022 and March 2023, six focus groups were conducted with 66 lay community members in three Florida cities – Jacksonville, Tallahassee, and Tampa. Data from the focus groups were transcribed verbatim. The transcripts were organized, coded, and analyzed utilizing NVivo qualitative software. Two reviewers identified key themes using the a priori objectives from the focus group guide. The general code list of themes was further refined after the reviewers’ initial coding pass.

RESULTS

Most participants were non-Hispanic (72%), Black or African American (62%). There were 39 males and 21 females, most (48%) between the ages of 25 – 34. Many participants perceived clinical trials as research to test treatments or medications. Only two had participated in a clinical trial. Motivations to participate primarily focused on helping others and the prospect of direct benefit of participation. Barriers identified focused mainly on fear of negative side effects and to a lesser degree, mistrust of research.

Suggested strategies for engaging racial and ethnic minorityemphasized the need for clear and detailed information about the procedures – such as blood draws, side effects, trial length and how the information would be used – during the initial advertising or recruiting for clinical trials. Most indicated that a trusted resource for information about clinical trials was their primary care physicians or health care providers, although none reported receiving information through this source.

DISCUSSION

Updated and more informative education regarding clinical trials should be made available in medical practices and community clinics to encourage more racial and ethnic minority populations 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 $707,281 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.