The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August.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?
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.
FDA Final Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Aug 31, 2017)
FDA Webinar: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Oct 10, 2017)
FDA Draft Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (CDRH, July, 2016)
Article: FDA Finalizes Guidance on Using Real World Evidence for Medical Device Regulatory Decisions (RAPS Focus, Aug 30, 2017)
Article: FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions (RAPS, Dec 8 2016)
Article: Real-World Evidence — What Is It and What Can It Tell Us? (NEJM, Dec 8, 2016)
Quotes by Mike:
“Real world evidence is how the products or devices are actually used in the real world, either by the physicians and surgeons or by individual patients.”
“Although the RCT is the gold standard, it is inherently biased.”
“Real-world evidence is data of a sufficient quality that it can be treated as evidence.”
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