Nat Turner Discusses the Challenges of Using Real-World Data in Clinical Trials
Real-world evidence isn't usually used for regulatory decisions, but the FDA is poised to start using it more, and there are challenges to using real-world data in clinical trials that will need to be navigated, said Nat Turner, co-founder and CEO of Flatiron Health.
Transcript (slightly modified) What are the challenges of using real-world data in clinical trials and getting the FDA to allow its use?
Large numbers, so you need a lot of it, you have to have tens of thousands of patients for certain use cases. FDA needs to apply, and they are, and it’s not necessarily randomized, although there are ways you can do that. It’s not necessarily prospective data so you need to think through quality control and methods for how you process that data. Probably a lot of human review at various steps of the way to make sure you’re interpreting things correctly.
Ultimately, real-world evidence is not really used for regulatory decisions right now, it’s more used for publications, supplemental data. The FDA will have to be the one ultimately to say: hey we’re going to make a regulatory—maybe approve an expansion of a label, for example, that’s going to have to be them. 21st Century Cures, which was the last bill President Barack Obama signed, gave them the runway, kind of the box to play in which said: use real-world evidence for was many things as you can. We’re going to see, and the new director, Scott Gottlieb is doing a lot of very cool things to push that agenda. We’ll see what happens.