Revisiting Real-World Evidence—Mike on Medtech

Revisiting Real-World Evidence—Mike on Medtech

Mike Drues and Sean Fenske look at new FDA guidance around RWE and discuss how it can be used within regulatory submissions.

By Sean Fenske, Editor-in-Chief06.18.24
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re revisiting real-world evidence (RWE), which is a topic that’s been getting some attention. So today, we’re going to look at what’s driving that attention and discuss the reasons behind it. We’ll also talk about how the FDA is seeking to use real-world evidence. Specifically, the following questions are addressed:

  • We’ve discussed real-world evidence previously, in podcasts from 2017 and 2020, but what’s the cause for us to do so today?
  • Without requiring people to go back and relisten to those previous podcasts—not that I’d object—can you please briefly explain what real-world evidence is? Could you also mention how it compares and contrasts with real-world data?
  • How does real-world evidence compare to what’s deemed the gold standard—randomized clinical trials?
  • Do you have any examples of how real-world evidence has been used in regulatory submissions?
  • FDA has a new draft guidance around real-world evidence. What’s actually new in this?
  • In your estimation, what are the limitations of the new guidance? Is it falling short of what its goal should be or is supposed to be?
  • Does the real-world data or evidence need to come from use within the U.S.?
  • In discussing the possibility of doing this topic, you mentioned manufacturers may be missing a real opportunity with real-world evidence. What do you mean by that?
  • What are the takeaways?

Listen to this discussion and see what you think of the use of real-world evidence. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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