Clinical trials to test stroke treatments don鈥檛 include enough women, a disparity that could be hampering efforts to develop better care.
Globally, about 14 million people have a stroke each year, and women make up about 48 per cent of cases. But women are under-represented in clinical trials to test new treatments.
at the George Institute for Global Health in Australia and her colleagues analysed 281 stroke studies from around the world 鈥� each involving at least 100 participants 鈥� listed on the from 1990 to the beginning of 2020. In total, the studies involved close to 600,000 people.
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The researchers then compared the number of women enrolled in each study with how many women actually have a stroke in the geographical region in which the study was conducted, predominantly in the US, Asia or Europe.
They found that, on average, just 40.1 per cent of study participants were women. 鈥淗aving more women in clinical trials [to make them] representative鈥� ensures that trials are generalisable to both women and men in terms of efficacy and safety,鈥� says Carcel.
The team also discovered that studies in Asia had the fewest women enrolled, making up just 37.5 per cent of the study participants on average even though about 47.7 per cent of strokes in Asia occur among women.
More differences were found when looking at trials that addressed particular subtypes of stroke. The researchers discovered that non-acute and rehabilitation stroke studies enrolled fewer women than those analysing acute stroke.
Carcel says this may be because these studies are more burdensome to participants because they typically last longer. 鈥淭his then may become less feasible for women who have children, grandchildren or partners to take care of,鈥� she says.
The team also saw no significant trends in how many women were recruited in these studies over the 30-year period. Carcel says she was surprised by this result because the authorities in some countries, including the US and the UK, have drawn up specific policies to tackle this issue in clinical research.
鈥淧olicies that require more women to be enrolled in trials need to be concerted in effort,鈥� she says. 鈥淭he policies need to be implemented, monitored and evaluated.鈥�
at the University of Leeds in the UK says he isn鈥檛 surprised by the findings, but agrees they are concerning. 鈥淲e know that women can have and respond to cardiovascular disease differently from men,鈥� he says, adding that our understanding of best treatments will continue to be limited until studies are designed to be more inclusive.
Neurology
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