The U.S. Food and Drug Administration has released an action plan for enhancing the collection and availability of clinical trial data on demographic subgroups, including patient populations divided by sex, age, race and ethnicity.
We know that richer information is collected when different subgroups are enrolled in pivotal studies for medical products, writes Margaret Hamburg, M.D., FDA Commissioner in an Aug. 20 blog post. This kind of enrollment in turn gives us greater assurance in the safety and effectiveness of the medical products used by a diverse population.
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