Women underrepresented in stroke trials
Women were found to be underrepresented in clinical trials looking at stroke when compared to the prevalence of stroke among women in the disease population, according to study results published in Neurology.
“There have been a few studies looking at the number of women enrolled in cardiovascular trials and whether this represents the number of women in the population with cardiovascular disease, but only two have been in stroke,” Cheryl Carcel, MD, of the George Institute for Global Health, University of New South Wales, Australia, told Healio Neurology. “For our study, we examined the representation of women in stroke trials and looked at different stroke subgroups, as well as type of trials (acute, prevention or rehab). By looking at these separately, we were able to tease out which type of trials need to improve their recruitment and retention of women.”
Carcel and colleagues analyzed data from 281 randomized controlled trials with 100 or more participants (total participants = 588,887) who enrolled between 1990 and 2020. They calculated the participation to prevalence ratio (PPR), or the percentage of women who participated in a trial against the prevalence of women in the disease population, to examine sex disparities in enrollment.
Results showed 37.4% of participants were women, signaling their representation at a lower proportion relative to their prevalence in the underlying population (mean PPR = 0.84; 95% CI, 0.81-0.87). Researchers noted the greatest differences in trials of intracerebral hemorrhage (PPR = 0.73; 95% CI, 0.71-0.74), trials wherein participants had a mean age younger than 70 years (PPR = 0.81; 95% CI, 0.78-0.84), non-acute interventions (PPR = 0.8; 95% CI, 0.76-0.84) and rehabilitation trials (PPR = 0.77; 95% CI, 0.71-0.83). Between 1990 and 2020, these findings did not significantly change.
“Researchers will need to do better in enrolling women in stroke trials, while clinicians can also speak to their patients about the benefits of participating in clinical trials,” Carcel said.