Just two-thirds of the pivotal clinical trials that were used to win prescription drug approvals in Europe reported any data on the race of the study participants, and less than one-third contained information about their ethnicity, a new analysis found.
Meanwhile, the percentage of Black participants decreased significantly in studies run between 2007 and 2019, while the percentage of Asian participants increased. In general, races other than white were underrepresented at least twice as often in pivotal trials during that time, according to the analysis by the Tufts Center for the Study of Drug Development.
“The concerning thing is making sure patient populations are receiving drugs that are safe and effective,” said Zachary Smith, project manager and data scientist at the Tufts Center. “And if we see a certain demographic is not really represented in trials for a drug, then it’s hard to be as confident in the safety and effectiveness as if it had been tested within a representative sample.”
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