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FDA Issues Draft Guidance on Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical

Monday, June 20, 2016  
Posted by: Sheri DeVinney
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FDA Issues Draft Guidance on Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

The Food and Drug Administration (FDA) released draft guidance today titled "Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies." Part of FDA's job is to monitor clinical trial participation and safety, and in doing so, the agency must also keep tabs on the breakdown of a trial's participants by sex, age, ethnicity, and race.

With this new guidance, FDA is making a renewed effort to encourage researchers to consider those factors when designing a study. The agency is continuing work on new guidelines in order to diversify participation in clinical trials, which, according to FDA, is necessary to get a robust read on the effectiveness of a drug or device. Additionally, the goal is to ensure transparency on the part of researchers about participant demographics.

You may submit comments here for this draft guidance by September 19, 2016.