A Comprehensive Analysis of Institutional and Nationwide Datasets Identifies Key Parameters that Influence Racial Minority Enrollment onto Clinical Trials

Abstract

<h3>Purpose/Objective(s)</h3> Minority accrual to clinical cancer treatment trials remains consistently low across the United States. We hypothesize that specific aspects of clinical cancer trials associate favorably with minority accrual, and may guide future clinical trial design. <h3>Materials/Methods</h3> We identified cancer treatment trials with a minimum of 10 patients at a multi-institutional NCI designated cancer center from 2010-2022. We also analyzed the National Cancer Database (NCDB) from 2004 to 2018 to assess co-variables that influence minority accrual across the United States. Racial minorities were defined as any non-white individual for both our institutional and NCDB cohorts. Our study endpoint was the probability of enrolling a minority patient on a clinical cancer treatment trial. Separate univariable and multivariable logistic regression were used to determine whether co-variables from either our institutional dataset or the NCDB associated with the study endpoint. P-values of less than 0.05 were considered statistically significant. All analysis was performed in R (R Foundation for Statistical Computing, version 4.0.2). <h3>Results</h3> We identified a total of 352 cancer treatment trials from our multi-institutional cohort. These trials enrolled a total of 7,981 patients, and a total of 969 minorities (12%). Clinical trials treating breast and genitourinary malignancies had a favorable association with accruing a minority patient when compared to other solid tumors (OR 1.32 95% CI 1.04-1.66 and OR 1.33, 95% CI 1.02-1.71). Phase II clinical trials had a less favorable association with accruing a minority patient (OR 0.75, 95% CI 0.62 – 0.91) when compared to early phase trials (pilot + phase I + phase I/II). Analysis of the NCDB identified 19,139 minorities enrolled on institutional or double-blinded clinical trials. Minorities enrolled on clinical trials were more likely to be female versus male (OR 1.22, 95% CI 1.09-1.37), un-insured versus private insurance or Medicare (OR 2.22, 95% CI 1.67 – 2.94 and OR 1.96, 95% CI 1.43 – 2.63), live within 30 miles of their hospital (OR 2.33, 95% CI 2.08 – 2.63), receive treatment at academic versus community facilities (OR 1.75, 95% CI 1.52-2.04), and be treated with surgery (OR 1.59, 95% CI 1.41 – 1.79). Minority patients enrolled on clinical trials were more likely to have breast and genitourinary cancers (OR 1.54, 95% CI 1.31 – 1.81 and OR 1.35, 95% CI 1.14 – 1.61). <h3>Conclusion</h3> Twelve percent of patients that enrolled on clinical trials in our institutional cohort were minorities, which is comparable to current minority representation in NCI trials. Our analysis found that minority patients enrolled on early phase clinical trials, breast and genitourinary treatment trials, tended to be female, un-insured, live within 30 miles of a facility, and receive surgical treatment. This analysis demonstrates that minority patients favorably associate with specific aspects of cancer treatment trials that should be addressed in future clinical trial design.