A global analysis of women's participation in cardiovascular clinical trials from 2018 to 2024

Abstract Introduction Cardiovascular disease remains a significant disease burden amongst woman globally. A previous analysis of cardiovascular clinical trials from 2010 to 2017 demonstrated that women's participation remains poor(1). This study seeks to provide an updated global analysis for trials conducted from 2018 to 2024. Methods A systematic search was performed in ClinicalTrials.gov for cardiovascular trials completed globally from 1 Jan 2018 to 31 Dec 2024. Publicly available data including sex participation, types of disease, sponsor, region, intervention were extracted. Outcomes included the median participation prevalence ratio (PPR) and female male ratio (FMR). The PPR was calculated by dividing the percentage of women in each trial by the percentage of women in the disease population from literature (PPR of 0.8 to 1.2: good representation). These were stratified by types of disease, sponsor, region, and intervention. Within-group difference was analysed by Kruskal–Wallis test, and post-hoc analysis using Dunn’s test with Bonferroni correction was performed to assess for statistically significant pairwise comparisons. A nonparametric test for trend was employed to analyse temporal trends of PPR. Results 754 completed cardiovascular trials were included totalling 455 943 adults, of whom 40.3% were women(Table 1). In terms of disease type, only arrhythmia and hypertension trials had good women representation (PPR: 0.82 and 0.95 respectively). Women were overrepresented in pulmonary hypertension trials (1.38), and this was significantly higher than all other disease types (P0.05). This was consistent in terms of median FMR (3.68, P0.05). For types of intervention, lifestyle trials had good representation (PPR 0.93) and was significantly higher than drug (0.72, P=0.0018) and device trials (0.70, P0.0001) (Figure 1). None of the intervention subgroups had a FMR of above 1.00. Women had good representation in trials conducted by research institutes (PPR 0.80), and those in Americas and Africa (0.88). Specifically, trials in American had a significantly higher PPR than those in Europe (0.80 vs 0.68, P=0.0078). There were no subgroups based on types of intervention, sponsor and region that had a FMR of above 1.00. There were no statistically significant associations between PPR, mean age(P=0.240) and trial size(P=0.638). There was an increasing overall PPR over time from 2018 to 2024 (P=0.0078). For heart failure trials, there was a statistically significant temporal trend in PPR, where it increased from 2018 to 2021 (0.484 to 0.760), dipped between 2022 to 2023 (0.741 to 0.700) before increasing in 2024 (0.778) (P=0.0004). Conclusions Consistent to the previous analysis of trials between 2010 and 2017(1), the participation of men in cardiovascular trials remains dominant globally from 2018 to 2024. However, there are trials with specific conditions, types of sponsors and interventions that have demonstrated good women representation.Table 1