Gender Disparities in Ischemic and Hemorrhagic Stroke Clinical Trials

Introduction: Despite facing disproportionately higher risks, burdens, and severe outcomes following stroke, women remain underrepresented in both ischemic and hemorrhagic stroke clinical trials, potentially limiting effective treatment intervention.

Methods: A systematic search of ClinicalTrials.gov was conducted to identify completed and terminated trials involving ischemic and hemorrhagic strokes from 1982 to 2022. Studies were assessed for the proportion of female participants using a Gender Disparity Index (GDI), calculated as (1/2) * |gender percentage - 50%|. A value greater than 10 indicated a study with significant gender disparity. Additional study-specific parameters—including trial year, duration, funding source, design, and phase—were collected. Univariate and multivariate analyses were performed to assess the association between these characteristics and gender disparities in participant enrollment.

Results: Among 348 included trials (n = 804,485 participants), 203 (58.3%) exhibited significant gender disparities (GDI > 10), in which Geographic Location emerged as a significant predictor of such disparity. Notably, stroke trials located in the Southern region of the United States had an average 26.1% reduction in GDI (p=0.01). When stratified by stroke type, ischemic stroke trials in the Southern region showed a 35.5% reduction in GDI (p=0.005), while hemorrhagic stroke trials in the Western region showed a 29% reduction in GDI (p=0.0465). Trials with significant gender disparity also reported lower participant completion rates (82.7%) compared to trials without such disparities (95.8%).

Conclusion : Persistent gender disparities in stroke clinical trials, influenced by geographic and regional factors, may impact participant completion rates and the generalizability of findings. Enhancing gender representation in these clinical trials is warranted, not only to improve the applicability of stroke interventions and therapies, but to enhance equitable access to stroke care for broader and more diverse patient populations.