​Consideration of sex/gender aspects in cardiovascular clinical trials

Abstract

Background: Understanding sex/gender in the context of health and disease is critical to deliver the best care. However, sex/gender have not been consistently considered in cardiovascular clinical trials. Global initiatives, including the Sex and Gender Equity in Research (SAGER)-guidelines, aim to improve the quality of the reporting, but it remains unclear if they are used consistently. Methods: We conducted a systematic analysis of cardiovascular clinical trials published in PubMed between 2018 and 2024. To investigate the representation of women/females, we first analyzed the participation-prevalence-ratio (PPR). Second, we measured sex/gender-sensitive reporting (SGR) applying modified SAGER-guidelines. In addition, we determined whether study author sex/gender impacts the other variables. Findings: We identified 1593 clinical trials with a total of 716,569 woman/female participants (38.5%). The median PPR of all trials remained suboptimal at 0.77 (95%-CI: 0.74–0.79) throughout the years with a modest positive trend towards 2024 and significant underrepresentation in some disease entities (e.g., ischemic heart disease, heart failure). Analyzing an evenly distributed sample of 632 trials, we found suboptimal SGR, especially for endpoints and discussions. We found a positive correlation of increased participation of women/females and SGR with women/females as authors. Interpretation: Our results suggest an ongoing imbalance for the participation of women/females and suboptimal SGR in cardiovascular clinical trials, especially for certain diseases, with a modest positive trend. More women/females in the authorship team correlate with an increased PPR and are associated with an increase in SGR.