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Women Underrepresented in Stroke Clinical Trials

Greatest differences seen for trials of intracerebral hemorrhage stroke type, nonacute interventions, and rehabilitation interventions

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THURSDAY, Oct. 14, 2021 (HealthDay News) -- Women are underrepresented in stroke clinical trials relative to the number who have strokes in the general population, according to a study published online Oct. 13 in Neurology.

Cheryl Carcel, M.D., from the University of New South Wales in Australia, and colleagues examined the participation of women in trials according to stroke prevalence in the population. A total of 281 stroke trials eligible for analyses were included (588,887 participants); results were published between 1990 and 2020. Sex disparities in enrollment were quantified by calculating the participation-to-prevalence ratio (PPR).

The researchers found that 37.4 percent of the participants in the trials were women. Relative to their prevalence in the underlying population of stroke patients, women were represented at a lower proportion in the trials (mean PPR, 0.84). The differences were greatest for trials relating to intracerebral hemorrhage, trials with a mean participant age of younger than 70 years, nonacute interventions, and rehabilitation trials (PPRs, 0.73, 0.81, 0.80, and 0.77, respectively). There was no significant change in these findings over time.

"Our findings have implications for how women with stroke may be treated in the future, as women typically have worse functional outcomes after stroke and require more supportive care," Carcel said in a statement. "We will only achieve more equitable representation of women in clinical trials when researchers look at the barriers that are keeping women from enrolling in studies and actively recruit more women."

Several authors disclosed ties to the pharmaceutical industry.

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