CE-454029-3 UNDER ENROLLMENT OF FEMALE PARTICIPANTS INTO ARRHYTHMIA CLINICAL TRIALS: IS THERE AN ASSOCIATION WITH THE SEX OF THE INVESTIGATOR?

Abstract

Cardiovascular clinical trials under-enroll women relative to the burden of cardiovascular disease in the population. Some factors associated with this have been older age of females with cardiovascular disease, hesitation to have procedures/devices, and sex-specific exclusion criteria; higher enrolment has been seen when the first or last author of the published manuscript is a female. To determine whether there is an association between the gender of the recruiting team and enrollment of female participants in arrhythmia clinical trials performed in Canada. Arrhythmia clinical trialists in Canada were contacted to provide information on gender of the site principal investigator (PI) and site co-investigators and the sex of the participants enrolled at each participating site.Information regarding Canadian sites only were included if the clinical study was international; prospective cohort studies were included.Studies performed between 2008 to the present were included.Chi-squared tests were used to determine whether there was an association between gender of the site principal investigator, co-investigators and number of females enrolled. There were four atrial fibrillation (AF) ablation trials, one AF registry and two ventricular tachycardia ablation trials comprising 2007 patients (461 females (23.0%)).There were 87 sites across the studies, 10 site PI were women, and 25 had at least one co-investigator that was a woman.The 10 site PIs that were women enrolled 461 participants, 33% of which were female; the 77 PIs that were men enrolled 1546 participants, 23% of which were female.(p<0.0001, see figure)There was no association between sites with co-investigators that were women and female enrolment into the studies.(p=0.1117) The overall proportion of enrolment of females into arrhythmia studies is low.In addition, site principal investigators that were women had a higher rate of overall recruitment into clinical studies, and had a higher rate of female study participants, as compared to site investigators that were men.Further study to improve under enrolment of female participants in arrhythmia studies, as well as identification of barriers, is required, to improve this for both men and women who are site investigators in clinical arrhythmia studies.