Enrollment of Diverse Populations in the INGENIOUS Pharmacogenetics Clinical Trial

Frontiers in Genetics
Ebony Shah-WilliamsTodd C Skaar

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 White...Continue Reading

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Citations

Jul 17, 2021·Clinical and Translational Science·Tiana LuczakJacob Brown
Jul 13, 2021·British Journal of Clinical Pharmacology·Emma F MagavernSandra Soo-Jin Lee

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Clinical Trials Mentioned

NCT02297126

Software Mentioned

INGEN
Statistical Package for the Social Sciences ( SPSS
REDCap

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