US FDA Invites Randomized Trial Designs With Real-World Elements

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 purposes, FDA officials encouraged industry to bring RWE proposals to...