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US FDA Invites Randomized Trial Designs With Real-World Elements

 
• By Sue Sutter

Agency is eager to engage with sponsors on ‘well thought-out proposals' to include real-world data sources in randomized studies, Office of New Drugs director Peter Stein says but adds that believability and robustness of the data are the agency’s primary concern.

Welcome mat outside the front door - Image
The welcome mat is out at the FDA for randomized studies that incorporate real-world data elements. • Source: Shutterstock

The US Food and Drug Administration’s door is open to drug developers interested in integrating real-world data elements into randomized trials, but some regulatory skepticism about the reliability and utility of such data may linger behind that door.

At a recent Duke-Margolis Center for Health Policy meeting on leveraging randomized clinical trials to generate real-world evidence for regulatory...

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