Representation in clinical trials sponsored by the United States Department of Veterans Affairs

Abstract

Background: This study was conducted to determine whether demographic representation among U.S. Department of Veterans Affairs (VA)-sponsored trials differs from trials without VA sponsorship, with reference to VA patient demographics.

Methods: U.S. clinical trials registered between 1 March 2000 and 1 February 2022 were stratified into VA and non-VA groups. Outcomes included the combined percentage of non-White participants in each trial and enrollment of each demographic subgroup. Trial strata were summarized using medians; Wilcoxon rank sum and one-sample signed rank tests were used to compare demographic representation between (i) VA and non-VA trials and (ii) VA trials and Veterans Health Administration (VHA) patient demographics, respectively.

Results: We identified 13,826 trials with available data, including 521 VA and 13,305 non-VA-sponsored trials. Median non-White enrollment was 68% greater in VA trials (P < .001) than in non-VA trials, driven by greater enrollment of Black participants (23.5% vs. 10.4%; P < .001). Black participant enrollment in VA trials exceeded representation among VHA beneficiaries (23.5% vs. 15.8%, P < .001).

Conclusions: This study highlights the increased Black representation in VA-sponsored clinical trials, which is greater than expected after accounting for VHA clinical population demographics. Partnership with the VA may represent a meaningful avenue for increasing Black representation in clinical trials.

Keywords: clinical trial; demographic representation; race; veterans affairs.