FACT OR MYTH: BLACK PATIENTS DO NOT WANT TO PARTICIPATE IN CLINICAL TRIALS

ABSTRACT

Introduction Underrepresentation of minority groups, particularly Black patients, has been a major issue for most clinical trials. A commonly cited reason is mistrust amongst Black patients due to historical abuse. In a Historically Black College and University (HBCU) at a major metropolitan area with predominant Black patient population, we examined the patient participation rate in a clinical trial compared to other study sites with primarily White patient population. Methods In April 2021, a large prospective, multi-center clinical trial designed to validate a multiomics blood test for early detection of CRC (PREEMPTCRC) was initiated at a HBCU. To optimize study recruitment, culturally-sensitive methods were employed, including racially congruent recruitment staff, and synchronized timing of consent/study procedures with pre-endoscopy COVID testing and clinic visits. Information for all eligible participants screened for the study were recorded and evaluated for a 7- month period (April 1 - October 31, 2021). The enrollment numbers (defined as those consented to the study and had blood samples drawn) for the HBCU and across all other study sites were compared. Demographic and socio-economic data for patients who enrolled and not enrolled at the HBCU were collected to identify potential factors that affect participation. Results During the study period, the number of patients enrolled at the HBCU site (N=229) was significantly higher than the average number enrolled across the other 168 sites (N=90, p<0.0001). In fact, the HBCU site ranked at the top 11th percentile for patient enrollment across all study sites. The main difference between the HBCU site and other study site was race participants at HBCU were 88.2% Black and 5.2% White, while at the other sites, the participants were 12.0% Black and 71.5% White (p< 0.0001). Comparison of demographic characteristics and socio-demographic data of the enrolled and not-enrolled subjects at the HBCU were similar (Table 1) and did not identify factors that affect participation in clinical trials. Discussion The enrollment of Black patients at a HBCU site was comparable to other study sites in a large prospective, multi-center study of a multiomics blood test for average-risk CRC screening. The findings of our study highlight the importance of providing access to Black patients to clinical trials to ensure adequate representation in research studies. (Table Presented) Table 1. Baseline Patient Demographic and Sociodemographic Information