Temporal Trends of Women Enrollment in Major Cardiovascular Randomized Clinical Trials

Abstract

Background: Although it is known that women do not participate in trials as frequently as men, there are limited recent data examining how women recruitment has changed over time.

Methods: We conducted MEDLINE search using a validated strategy for randomized trials published in New England Journal of Medicine, Lancet, and Journal of the American Medical Association between 1986 and 2015, and included trials evaluating pharmacologic or nonpharmacologic therapies. We abstracted data on demographics, intervention type, clinical indication, and trial design characteristics, and examined their relationships with women enrollment.

Results: In total, 598 trials met inclusion criteria. Women enrollment increased significantly over time (21% between 1986 and 1990 to 33% between 2011 and 2015; P_{for trend} < 0.001) and did not differ by journal or funding source. Women enrollment varied with clinical indication, comprising 37% for non-coronary artery disease vascular trials, 30% for coronary artery disease trials, 28% for heart failure trials, and 28% for arrhythmia trials (P < 0.001), which were all significantly lower than the expected proportion in disease populations (P < 0.001). Women enrollment varied with trial type (31%, 29%, and 26% for pharmacologic, device, and procedural trials, respectively; P = 0.001). These findings were corroborated using multivariable analysis. We found significant positive correlations between women enrolled, and mean age and total number of participants. Fewer women were enrolled in trials reporting statistically significant results than those who did not (P = 0.001).

Conclusions: Although enrollment of women has increased over time, it remains lower than the relative proportion in the disease population. Future studies should elucidate the reasons for persistent under-representation of women in clinical trials.