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 global burden of cardiovascular disease (CVD). This study evaluated the impact of trial characteristics on the temporal enrollment of women and racialized minorities in prominent cardiovascular trials published between 1986-2023. Methods 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 according to the enrollment of women or racialized minorities. Results From 799 studies, including 4,071,921 patients, the enrollment of women and racialized minorities significantly increased from 1986-2023 (both P = < 0.001). Although the enrollment of women varied by trial indication, comprising 25.0% of coronary artery disease (CAD), 35.2% of non-coronary/vascular, 13.8% of heart failure (HF), 17.0% of arrhythmia and 28.7% of other cardiovascular trials ( P = < 0.001), it did not differ by peer-reviewed vs industry funding. First authors who were women were more likely to enroll significantly more women than first authors who were men ( P = 0.01). Racialized enrollment increased significantly from 1986-2023 ( P = < 0.001). Conclusions 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.