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Amid concerns that clinical trials do not adequately represent patient populations, a new analysis finds a substantial portion of so-called pivotal studies failed to break out data on the race and ethnicity of participants. And at the same time, fewer women participated in trials than might have been expected.

Over a recent 10-year period, only 37% of 775 pivotal trials – which are the late-stage studies used to win regulatory approvals – provided data on ethnicity. And only 73% of the studies broke out participation by race. However, trial sponsors did a better job of disclosing the sex and age of participants – 90% and 83%, respectively.


Meanwhile, more than 252,000 women participated in pivotal trials that were used to support FDA approvals, or 45% of all participants, between 2007 and 2017. But this was roughly 20,000 less than had been anticipated, based on the prevalence of diseases that typically affect women, according to the analysis, which was conducted by the Tufts Center for the Study of Drug Development.

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