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Episode 52  |  35:45 min

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

Episode 52  |  35:45 min  |  11.07.2019

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

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This is a podcast episode titled, Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions. The summary for this episode is: The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective? Today we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives. Some of the highlights of the show include: ● Why medical device companies should care about real-world evidence and why it’s as important and more realistic than the “gold standard” of randomized clinical trials. ● Reasons that a clinical trial can be less informative than real-world evidence and how the FDA is beginning to change its thoughts on accepting real-world evidence. ● Thoughts on why the quality of the real-world data is important when it comes to getting FDA to accept it. ● The mechanism of going down the path of using real-world evidence in regulatory matters. ● How real-world evidence might be used even after a device or product is already on the market, either in lieu of a clinical trial or as a reason to use a smaller clinical trial. ● Thoughts on the future of credible real-world evidence. ● Examples of how real-world evidence can be used.
The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective? Today we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives. Some of the highlights of the show include: ● Why medical device companies should care about real-world evidence and why it’s as important and more realistic than the “gold standard” of randomized clinical trials. ● Reasons that a clinical trial can be less informative than real-world evidence and how the FDA is beginning to change its thoughts on accepting real-world evidence. ● Thoughts on why the quality of the real-world data is important when it comes to getting FDA to accept it. ● The mechanism of going down the path of using real-world evidence in regulatory matters. ● How real-world evidence might be used even after a device or product is already on the market, either in lieu of a clinical trial or as a reason to use a smaller clinical trial. ● Thoughts on the future of credible real-world evidence. ● Examples of how real-world evidence can be used.

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