A new study published in Neurology shows that women are underrepresented in stroke clinical trials compared to the proportion who have strokes in the general population.
“Making sure there are enough women in clinical studies to accurately reflect the proportion of women who have strokes may have implications for future treatment recommendations for women affected by this serious condition,” said study author Cheryl Carcel, MD, of The George Institute for Global Health in Sydney, Australia. “When one sex is underrepresented in clinical trials, it limits the way you can apply the results to the general public and can possibly limit access to new therapies.”
The study analysed 281 stroke trials conducted between 1990 and 2020, with a total of 588 887 participants. Of these, only 37.4 % were women. The average prevalence of stroke in women across the countries included was 48%.
Results were calculated in participation-to-prevalence ratio, a relative measure that weights the percentage of women in a trial compared to their proportion in the total population with that disease. A ratio of one indicates that the percentage of women in the study is the same as the percentage of women with the disease in the general population. An acceptable range for an ideal ratio of female participation is between 0.8 and 1.2.
Overall, women were found to be underrepresented relative to their prevalence in the underlying population, with a consistent ratio of 0.84 over time. They found the greatest differences in trials of intracerebral haemorrhage, with a ratio of 0.73; trials with average participant age under 70, with a ratio of 0.81; non-acute interventions, with a ratio of 0.80; and rehabilitation trials, with a ratio 0.77.
“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,” Dr Carcel said. “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. People who fund the research also need to demand more reliable, sex-balanced evidence.”
Source: American Academy of Neurology