(CCSP101) TEMPORAL TRENDS OF ENROLLMENT BY SEX AND RACE IN MAJOR CARDIOVASCULAR RANDOMIZED CLINICAL TRIALS

Background: Women and racialized minorities continue to be underrepresented in cardiovascular trial outcomes data, despite comprising a significant burden of cardiovascular disease (CVD) worldwide. This study evaluated the impact of trial characteristics on the temporal enrollment of women and racialized minorities in prominent cardiovascular trials published between 1986-2022.

METHODS AND RESULTS: MEDLINE was searched for cardiovascular trials published in the Lancet, Journal of the American Medical Association, and the New England Journal of Medicine. Participant and investigator demographics, types of interventions, clinical indications, and funding sources were compared with the enrollment of women or racialized minorities. From 768 studies, including 3,936,290 patients at 131,304 centres, the enrollment of women and racialized minorities significantly increased from 1986-2022 (both P = < 0.001). While the enrollment of women was similar despite the type of trial funding (peer-reviewed vs industry funding), this differed significantly by trial indication, comprising 56.4% of coronary artery disease (CAD), 37.1% of non-coronary/vascular, 26.0% of heart failure (HF), 29.5% of arrhythmia and 29.5% of other cardiovascular trials (P = < 0.001). Female first authors were more likely to enroll significantly more women than male first authors (P = 0.04). Racialized enrollment increased significantly from 1986-2022 (P = < 0.001).

Conclusion: Active efforts to increase diverse enrolment, along with improved reporting, including sex and race, in future cardiovascular trials may increase the generalizability of their findings and applicability to global populations.