Clinical Trials of Stroke may Not be as Accurate for Women

Clinical trials in stroke are found to underrepresent women as compared relative to those in the general population.

Clinical trials in stroke are found to underrepresent women as compared to relative to those in the general population as per a study published in the Neurology®, the medical journal of the American Academy of Neurology.

“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. 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,” says study author Cheryl Carcel, MD, of The George Institute for Global Health in Sydney, Australia.

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‘Clinical trials in stroke are found to underrepresent women as compared relative to those in the general population. ’

The study analyzed 281 stroke trials with at least 100 participants that were conducted between 1990 and 2020. Among the total number of 588,887 participants, only 37.4 % were women. However, the global average prevalence of stroke among women was 48%.

The study results were based on participation-to-prevalence ratio (normal range 0.8 to 1.2) – a relative measure that weights the percentage of women in a trial compared to their proportion in the total population with that disease.

Ratio of Women

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This method is utilized to confirm if enough women are recruited to make accurate conclusions of a study. However, the present study found that the overall representation of women in studies was only 0.84 – a relatively lower proportion.

Moreover, trials of intracerebral hemorrhage revealed a ratio of 0.73, 0.81 in trials with average participants below 70 years of age, 0.80 in non-acute interventions trials, and 0.77 in rehabilitation trials.

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Stroke is a brain attack, which occurs when the blood supply to the brain is interrupted. It affects all age groups; according to the WHO, 15 million people are affected by stroke annually.

“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. 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,” says Carcel.

However, the study has its limitation as the registries were included only from a U.S. government website and this may enforces further studies to be included for capturing all the stroke trials.

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Source-Medindia