Race, Ethnicity Categories Proposed for Drug Trials. (Responses May Differ)

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ROCKVILLE, MD.--A standardized approach to collecting data in people from different ethnic and racial groups in new drug trials has been recommended by the Food and Drug Administration.

The proposal reflects the increased awareness that responses to drugs are not always uniform across the population.

The FDA's draft "Guidance for Industry" document provides recommendations on different categories of ethnic and racial demographic groups to use when collecting effectiveness and safety data in clinical trials. Using standardized categories when collecting such data "will enhance the early identification of differences in response among racial and ethnic groups during …