Abstract 14122: Evaluating Gender Diversity in Principal Investigators of Cardiac Electrophysiology Clinical Trials
Shirin Sadri, Grace A Soontornviwath, Alice Ku, Crystal O Bernardez, Tawfique Ali, Ananya Khosla, Khusbu K Adhikari, Angelina S Duran, Joseph-Kelvin Igwe, Kira Clark, Erin Rose R Cruz, Muhammed Y Idris, Peter Poullos, VJ Periyakoil, Bryant Lin, Latha Palaniappan, Celina M Yong, Anekwe Onwuanyi, Melvin Echols, Paul J Wang, Ridhima Kapoor- Physiology (medical)
- Cardiology and Cardiovascular Medicine
Background: Importance of diversity in clinical trial participants has been recently highlighted. Though clinical trials led by women principal investigators (PIs) are more likely to enroll diverse participants, the proportion of trials led by women PIs is unknown.
Objective: To evaluate gender distribution among PIs who conduct NIH and industry-funded clinical trials in cardiac electrophysiology (EP).
Methods: NIH and industry-funded trials in the clinicaltrials.gov registry completed between 1/1/2002 and 12/31/2021 in atrial fibrillation (AF), implantable cardioverter defibrillators (ICDs), pacemakers (PPMs), sudden cardiac arrest (SCA), and ventricular tachycardia (VT) were included. PI names and associated institutions were used to determine gender pronouns on institutional websites or social media. Trials with unidentifiable PI gender were categorized as unknown.
Results: 51 NIH-funded and 429 industry-funded trials in AF, SCA, VT, ICDs, and PPMs and 573 total PIs were identified. 128 trials (26.7%) and 123 PIs (21.5%) had unknown PI gender. 16.4% of all trials in which PI gender was known were led by women. 9/49 (18.4%) NIH and 49/295 (16.6%) industry trials were led by women. VT trials had the lowest proportion women-led (NIH: 0/4, 0%; industry: 3/26, 11.5%), whereas PPM trials had the highest proportion women-led in both NIH (3/5, 60%) and all trials (12/48, 22.2%). Of the group with the largest number of trials (AF), 12.9% were women-led (22/170) (Table). Of 450 PIs across all trials whose gender was identified, 14.4% were women. The proportion of women PIs decreased non-significantly over time. Studies between 2002-2011 were 16% women-led, and in 2012 or later this reduced to 13% X 2 (1, N = 450) = 0.81, p > .05.
Conclusion: The proportion of cardiac EP clinical trials led by women PIs remains low and has not increased. Urgent efforts are needed to implement strategies to increase leadership roles in clinical trials for women in cardiac electrophysiology.