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Demographic Representation in Clinical Trials Sponsored by the United States Department of Veterans Affairs. International journal of radiation oncology, biology, physics Gomez, G. T., Turner, B. E., Steinberg, J. R., Wren, S. 2023; 117 (2S): e20

Abstract

Non-White racial and ethnic groups remain underrepresented in oncology clinical trials within the United States and face ongoing barriers to participation. Previous reports cite positive attitudes toward clinical trials (CTs) among veterans, with altruism and a strong sense of community posited as driving forces for participation. Our objective was to characterize demographic representation among CTs sponsored by the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) compared to trials with no VA/DoD sponsorship.We incorporated data from U.S. CTs registered in ClinicalTrials.gov between March 2000 and March 2020 using the Aggregate Analysis of ClinicalTrials.gov database, and stratified CTs by sponsorship into the following groups: (1) VA, (2) DoD or (3) non-VA/DoD sponsorship. We extracted CT enrollment data for gender and four race/ethnicity categories: White, Hispanic/Latinx, Black, and Asian. After calculating gender and race-specific proportions for each CT, we compared the median proportion of White, non-White, Black, Asian, and Hispanic participants between (a) VA and non-VA/DoD CTs, (b) DoD and non-VA/DoD CTs, and (c) VA CTs and the Veterans Health Agency (VHA) patient population using Wilcoxon signed rank tests.This study included 13942 CTs; of these, 490 (94%) VA, 38 (95%) DoD, and 12574 (95%) non-VA/DoD sponsored CTs reported race/ethnicity data. Non-VA/DoD entities sponsored a greater relative number of oncology CTs (29%) than did the VA (5%) or DoD (3%). Characterization of CTs by participant race/ethnicity demonstrated median non-White enrollment was 68% greater in VA CTs (p<0.001) and 34% greater in DoD CTs (p?=?0.138) than non-VA/DoD CTs. Increased non-White VA CT enrollment was driven largely by the higher median proportion of Black participants (24%)-more than double that of non-VA/DoD CTs (10%) (Table 1). Comparison between the median proportion of Black participants in VA CTs and VHA patient demographics (15.8% Black) revealed that VA CTs enroll a greater percentage of Black participants than reflected in the VHA patient population (p<0.001).This characterization of veteran involvement in CTs demonstrates that VA sponsored CTs feature significantly greater representation of minorities, a pattern driven exclusively by greater enrollment of black patients. This work prompts further exploration into modeling VA enrollment strategies in non-VA CTs and increasing VA sponsorship of cancer trials to stimulate inclusion of underrepresented populations in oncology CTs.

View details for DOI 10.1016/j.ijrobp.2023.06.691

View details for PubMedID 37784849