Background: Women are consistently underrepresented in clinical stroke trials ,despite experiencing a higher lifetime stroke risk and poorer post-stroke outcomes. Disparities in participation may be influenced by trial type, and stroke phase. Understanding gender-specific barriers is essential to improving inclusivity and ensuring representative trial populations.
Aim: To evaluate the trend in non-participation in stroke clinical trials by gender, trial type, and onset phase.
Methods: Retrospective observational study of adult stroke patients aged ≥ 18 years, admitted to the Alfred Health Comprehensive Stroke Centre between February 2019-March 2025.
Results: Of 494 eligible stroke patients (female: 235[47.6%]; male: 259[52.4%]), 340(68.8%) consented to participate, including 134/235 females (57.0%) and 206/259 males (79.5%) (p < 0.001). 109 patients declined (female: 63/235 [26.8%]; male: 46/259 [17.8%]), and 45 were not approached (female: 38/235 [16.2%]; male: 7/259 [2.7%]).
Declines were most frequent in interventional trials (female: 41/146 [28.1%]; male: 34/185[18.4%], p <0.05), then non-interventional (female: 17/71 [23.9%]; male: 8/47 [17.0%]) and observational trials (female: 6/18 [33.3%]; male: 6/27 [22.2%]).
By onset phase, declines were highest during the acute phase (female: 31/122 [25.4%]; male: 30/141 [21.3%]), then chronic (female: 27/92 [29.3%]; male: 17/98 [17.3%]). In the hyperacute phase, declines occurred only among females (6/19 [31.6%]; male: 0/17, p <0.01). In the subacute phase, one male declined (1/3 [33.3%]) and no declines were recorded among females (0/2).
Conclusions: Interventional and acute-phase trials exhibit pronounced gender disparities at our centre. Female patients demonstrated significantly reduced participation. Further understanding of gender disparities in clinical stroke research trials is required.