The proportion of women involved in trials of experimental drugs for Alzheimer's disease (AD) is significantly lower than the proportion of females in the general population affected by AD, as well as being lower than the proportion of women included in older trials for already approved drugs, according to a new study published by Women’s Brain Project (WBP) in the Journal of the American Medical Association (JAMA) Network Open.
Most publications did not report treatment outcomes by sex and the WBP study launches a call to action for the development and implementation of strategies to ensure optimal representation of both sexes in clinical trials and publication of sex-stratified results. In the new publication “Proportion of women and reporting of outcomes by sex in clinical trials for Alzheimer Disease: A systematic review and meta-analysis,” a pool of researchers led by WBP has conducted a systematic review and meta-analysis of 56 randomised clinical trials for AD, with the aim of describing the current sex proportion and consideration of sex differences in clinical trials.
The randomised clinical trials examined included a total of 39,575 participants, 59% of those being women. The proportion of women differed across studies, though; in fact, the randomised clinical trials for AD which led to drug approval had a proportion of 67.3% female in contrast to 57.9% for experimental drugs. While the overall proportion of women in experimental trials is still higher than that of men, this is significantly lower than the female prevalence of the disease in the real-world population with AD in both Europe and the US (between 62 and 68%), the paper showed.
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