Abstract of the day – Representation of female participants in cardiovascular trials by disease type and over time – is there any improvement?
31 Aug 2025
Abstract of the Day Historically, women have been underrepresented in cardiovascular disease (CVD) trials, despite facing a disproportionately high burden of many forms. Today, Professor Martha Gulati (Cedars-Sinai Smidt Heart Institute - Los Angeles, USA) presents a systematic review that assessed representation of women across a broad range of CVD trials.
In total, 1,079 randomised trials in related areas (cardiovascular, cardiometabolic and obesity) were identified from ClinicalTrials.gov between 2017 and 2023. Of the 1,396,104 participants, 40.9% were women. Female participation was most common in trials studying lifestyle interventions (55.8%) and least common in trials related to procedures (28.4%). By age, females who were 19–55 years old had the highest participation rates at 46.7%, while the lowest was observed in females aged 61–65 years (32.2%). By region, female participation was most common in the USA (45.4%) and least common in Asia (28.8%). By sponsor type, research institute-led studies had the highest female participation at 49.9%, while only 6.6% of participants in government-led studies were women.
When the female participation-to-prevalence ratio (PPR) was estimated based on the relative prevalence of the disease by sex in the region, there was a trend towards an increase in female PPR from 2017 to 2023 (p=0.056). Overall, female PPRs were low for trials on arrhythmias (0.59), coronary heart disease (0.66) and acute coronary syndrome (0.71), were adequate on heart failure (0.80) and were high on obesity (1.30) and pulmonary hypertension (1.44).
The authors conclude that there is wide variation in female representation in cardiovascular trials by disease state, intervention, region and sponsor type. They highlight that a better understanding of the reasons for these differences may enable tailored strategies to be implemented to improve female representation globally and across therapeutic areas.
