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Home » NASEM Calls for Action by FDA to Improve Device Trial Diversity
NASEM Calls for Action by FDA to Improve Device Trial Diversity
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require sponsors to file an in-depth recruitment strategy, either before or with their investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics.