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Race, ethnic clinical trial data guidelines issued

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WASHINGTON — New guidelines for collecting data on race and ethnicity in clinical trials have been published in draft form by the Food and Drug Administration.

FDA regulations require drug sponsors to present an analysis of data according to age, gender and race. Collecting race and ethnicity data using standardized categories will enhance the early identification of differences in response among racial and ethnic groups during the evaluation, according to an FDA press release.

To view the draft guidance, go to http://www.fda.gov/cder/guidance/5054dft.doc