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.
To View This Article:
Subscribe To Device Daily Bulletin Premium
Device Daily Bulletin Premium Subscription
Upgrade to Device Daily Bulletin Premium to get all the articles in the free publication PLUS more in-depth stories on regulatory and industry developments, FDA inspection and enforcement activities and analysis of market trends. It makes sense of everything successful devicemakers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay compliant and thrive. And it’s combined with timely content from FDAnews management reports and webinars. Learn more