A new study published in the journal Neurology reveals that women are underrepresented in stroke clinical trials relative to the number of stroke patients in the general population.
The study looked at 281 stroke trials with at least 100 participants conducted between 1990 and 2020. The total number of participants was 588,887, of which 37.4% were women. However, the average prevalence of stroke in women in the included countries was 48%.
“Ensuring that there are enough women in clinical studies to accurately reflect the proportion of those with stroke may have implications for future treatment recommendations for women affected by this serious condition,” explains study author Cheryl Carcel. Researcher at The George Institute for Global Health in Sydney, Australia. ” When one sex is underrepresented in clinical trials, it limits how you can apply the results to the general public and can possibly influence access to new therapies .”
Results were calculated using the participation / 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. It is a simple way to know if a research project has recruited enough women to be able to draw accurate conclusions about the findings. A ratio of one means 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 proportion of female participation is between 0.8 and 1.2.
The researchers found that, overall, women were represented in a lower proportion relative to their prevalence in the underlying population , and this did not change over time. They found the largest differences in the intracerebral hemorrhage trials, with a ratio of 0.73; trials in which the average participant was less than 70 years old, with a ratio of 0.81; non-acute interventions, with a ratio of 0.80; and rehabilitation trials, with a ratio of 0.77.
“Our findings have implications for how women with stroke can be treated in the future, as women tend to have poorer functional outcomes after stroke and require more supportive care,” explains Carcel. “ We will only achieve a more equitable representation of women in clinical trials when researchers take into account the barriers that prevent women from enrolling in studies and actively recruiting more women. People who fund research should also demand more reliable and gender-balanced tests. “
One limitation of the work, the authors acknowledge, is that it only included studies registered on a US government website, so it may not have accounted for all stroke trials.
