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Six years ago, the U.S. Food and Drug Administration launched a five-year action plan to improve the diversity and transparency of pivotal clinical trials for newly approved medicines. But a new analysis finds the effort failed to make a difference for Black patients, whose participation in clinical trials remained inadequate.

Specifically, Black people accounted for just one-third of the required enrollment for adequate representation, regardless of whether the trials started before, during, or after the FDA plan went into effect. Of 225 drug approvals for which mortality and morbidity information was listed on the FDA plan website, only 20% had data showing benefits and side effects for Black patients, according to the analysis, which was published in Health Affairs.


Overall, Black individuals were under-represented in 85% of all trials and every disease category except psychiatry, although this exception was largely attributed to studies for one particular drug. Black patients were least represented in clinical studies for cardiovascular disease medicines. Yet in 2018, Black people were 30% more likely to die from heart disease than non-Hispanic white patients, according to federal data.

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