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
ABSTRACT
Introduction: Clinical trials often have low enrollment of minorities, particularly African-Americans (AAs), which may limit the generalizability of research findings. Previously identified barriers to AAs recruitment include historical abuses leading to mistrust, communication issues with providers, socio-economic factors, and a lack of access to clinical trials. In a Historically Black College and University (HBCU) serving a primarily AA population at a large safe-net hospital, we evaluated the enrollment of eligible AA patients for a colorectal cancer (CRC) screening clinical trial. This was compared to the enrollment rates across other study sites. Methods: A large, prospective, multi-centered clinical trial to validate a blood-based test for early detection of CRC (PREEMPT-CRC) was initiated at a HBCU, where 84% of patients are AAs. To maximize study recruitment, culturally sensitive methods were employed including racially congruent recruitment staff as well as synchronized timing of consent/study procedures with preendoscopy COVID testing/clinic visits. Detailed information for all eligible subjects was recorded. Demographic and socio-economic data including census information for enrolled and not enrolled subjects were compared. The enrollment rate (defined as enrolled/eligible patients) over the first 6 weeks at the HBCU and that of the other study sites providing screening logs was analyzed. Results: The enrollment rate at the HBCU was 55% (44 out of 80 eligible patients;95% CI 43.5- 66.2%), compared to 49.8% (258 out of 518 eligible patients;95% CI 45.4- 54.2%) at the other 26 study sites. While age and gender of enrolled patients at the HBCU were comparable to other sites, the main difference was race: at the HBCU the study participants were 79.5% AAs and 9.1% whites, while at the other sites the participants were 11.5% AAs and 82.8% whites (p< 0.001). At the HBCU, the demographic characteristics and socio-demographic data including income, marital status insurance status/type, and census tract median household income of the 44 enrolled and 36 notenrolled subjects were similar (Table 1). Conclusion: Contrary to conventional belief that AAs do not want to be involved in clinical trials, we find their enrollment is similar to a predominant white study population when offered the opportunity in a culturally sensitive setting. Future trials should consider including HBCU sites in order to attain adequate AA enrollment to improve the generalizability of research findings. (Table Presented).