Little progress has been made over the last decade in improving gender balance in leadership positions within cardiovascular clinical trials.
This is the stark assessment set out in a research letter published in the Journal of the American College of Cardiology (JACC) this month, in which Celina Yong (Stanford University School of Medicine, Palo Alto, USA) chart the gender trends among the principal investigators and patients enrolled in cardiovascular trials over time.
Yong and colleagues note that their finding has likely implications for our understanding of sex differences in cardiovascular care, as trials with female principal investigators tend to be those that enrol the greatest proportion of female patients.
Covering all cardiovascular National Institutes of Health (NIH) and industry-funded studies appearing publicly on the ClinicalTrials.gov website from 2010–2019, totalling 620, the study found that industry-funded studies and device trials are among those to have lagged the furthest behind.
Women served as principal investigators in 18.4% (114) of all the trials included in the analysis, with female leadership most common in ischaemic heart disease (23.9%, 27), stroke (11.5%, 13), and arrhythmia (10.6%, 12) trials respectively.
Compared with studies that were led by men, women-led trials tended to enroll more female participants, with around 44.9% female participants in studies with a female principal investigator, compared to 37.9% in studies led by men. Women led 34% of pulmonary hypertension trials, where they recruited roughly 76.6% female participants, compared to 71.6% in those with male principal investigators.
Authors of the study suggest that there are a multitude of reasons to explain the disparity, not least what they describe as “stark” gender gaps in senior academic positions and the cardiovascular profession.
“Given the trial types do not track directly to subspecialties, it is difficult to determine whether current trial leadership represents the 14.9% women in cardiology and 30.9% in neurology,” Yong et al write. “However, device trials—which align closely with invasive specialties—appeared to closely mirror proportions of women in interventional cardiology and electrophysiology (8‒9%).”
Further research is needed to address whether persistent gaps reflect a time lag in the effects of new practices or unresolved disproportionate barriers, the authors add, noting that efforts to prioritise equity in the grant funding process may further close gaps.
“Leadership in trials is a path to leadership in the profession, so addressing structural barriers in the clinical trial space is essential to creating equity in the field,” Yong and colleagues conclude their paper. “This study highlights specific targets for improvement and the collateral benefit of more diverse trial enrolment.”
