Presentation Title: Enrollment of Diverse Populations in the INGENIOUS Clinical Trial
Author Name(s): E Shah-Williams, KD Levy, Y Zang, AM Holmes, C Stoughton, P Dexter, TC Skaar
Author Department and School Affiliation: Indiana University School of Medicine Medical & Molecular Genetics.
Abstract: Recruitment of diverse populations and subjects living in Medically Underserved Areas and Populations (MUA/P’s) into clinical trials is a considerable challenge. To identify enrollment variables that predict enrollment in a diverse underserved population, we analyzed data from the INGENIOUS, (Indiana GENomics Implementation and Opportunity for the UnderServed), pharmacogenomics 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, p<0.002; Academic hospital, OR=0.64, 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 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. In conclusion, African-Americans can be readily recruited to pharmacogenetic clinical trials once contact has been successfully initiated. Enrollment could be further enhanced by improving research awareness of clinical trials, including diverse recruiters who represent the communities they enroll, reducing time needed for participation, and compensating for travel.