Abstract
Recruitment of diverse populations and subjects living in Medically Underserved Areas and Populations (MUA/P’s) into clinical trials is a considerable challenge. Likewise, representation of African-Americans in pharmacogenetic trials is often inadequate, but critical for identifying genetic variation within and between populations. To identify enrollment patterns and variables that predict enrollment in a diverse underserved population, we analyzed data from the INGENIOUS (Indiana GENomics Implementation and Opportunity for the UnderServed), pharmacogenomics implementation clinical trial conducted at a community hospital for underserved subjects (Safety net hospital), and a statewide healthcare system (Academic hospital). We used a logistic regression model to identify patient variables that predicted successful enrollment after subjects were contacted and evaluated the reasons that clinical trial eligible subjects refused enrollment. In both healthcare systems, African-Americans were less likely to refuse the study than non-Hispanic Whites (Safety net, OR = 0.68, and p < 0.002; Academic hospital, OR = 0.64, and p < 0.001). At the Safety net hospital, other minorities were more likely to refuse the study than non-Hispanic Whites (OR = 1.58, p < 0.04). The odds of refusing the study once contacted increased with patient age (Safety net hospital, OR = 1.02, p < 0.001, Academic hospital, OR = 1.02, and p < 0.001). At the Academic hospital, females were less likely to refuse the study than males (OR = 0.81, p = 0.01) and those not living in MUA/P’s were less likely to refuse the study than those living in MUA/P’s (OR = 0.81, p = 0.007). The most frequent barriers to enrollment included not being interested, being too busy, transportation, and illness. A lack of trust was reported less frequently. In conclusion, African-Americans can be readily recruited to pharmacogenetic clinical trials once contact has been successfully initiated. However, health care initiatives and increased recruitment efforts of subjects living in MUA/Ps are needed. Enrollment could be further enhanced by improving research awareness and knowledge of clinical trials, reducing time needed for participation, and compensating for travel.
Highlights
Randomized clinical trials are the gold standard for testing the safety and efficacy of therapeutic products, medical devices and clinical procedures (Minneci and Deans, 2018)
Subjects living outside of Medically Underserved Areas and Populations (MUA/P’s) were 53.7%, while subjects living inside MUA/P’s were 45.3%. 36.8% self-identified as non-Hispanic White, 53.8% African-American, and 9.4% self-identified as Native Hawaiian or Pacific Islander, Indian or Alaska Native, Asian, more than one race, or refused to answer
African-Americans were less likely to refuse the study than nonHispanic Whites (OR = 0.68, Confidence interval (CI) 0.53–0.86, and p = 0.002), while other minorities were more likely to refuse the study than non-Hispanic Whites (OR = 1.58, CI 1.02–2.45, and p = 0.04; Table 2)
Summary
Randomized clinical trials are the gold standard for testing the safety and efficacy of therapeutic products, medical devices and clinical procedures (Minneci and Deans, 2018). African-Americans, who are disproportionally diagnosed with higher rates of various diseases such as hypertension, diabetes, and stroke, compared to non-Hispanic Whites, are historically underrepresented in clinical trials (Thorpe et al, 2016; Musemwa and Gadegbeku, 2017; No author list, 2018). This creates racial disparities in receiving benefits from clinical trials. It often limits the ability of researchers to extrapolate the findings and use pharmacogenomics to personalize drug therapies across races (Perera et al, 2014; Shendre et al, 2018). Racial disparities exist in the incidence of adverse drug events, making minority populations important to include in pharmacogenetic clinical trials (Moffett et al, 2013; Chalasani et al, 2017)
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