Real world evidence used in regulatory decisions re marketing approval?

i didn’t know about this until @timdisher mentioned it on twitter:Aetion Announces Partnership with the U.S. Food & Drug Administration and Brigham and Women’s Hospital/Harvard Medical School to Integrate Real-World Evidence into Regulatory Decision-Making The article is a year old and im completely behind on it. It says:

“to see whether the use of RWE would have led to the same regulatory decisions. The results will demonstrate whether RWE could be used to supplement or, in certain circumstances, even replace clinical trials for drug development and regulatory approval”

are the results in? How do you “re-create randomized clinical trials (RCTs) through real-world evidence (RWE)”. The whole thing has the feel of marketing:

“The Aetion Evidence Platform uses the everyday clinical and financial interactions of the health care system to unlock essential evidence about the effectiveness and value of treatments. Its validated, rapid-cycle analytics™ allows users to significantly reduce “time to evidence” and improve patient outcomes.”

Can anyone point me to a paper (from industry?) and/or offer their thoughts. cheers

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A lot of discussions around this are going on in industry. We recently held an event in Basel with talks from industry, Flatiron, and European regulators. Find the slide decks here: http://bbs.ceb-institute.org/?p=1248

This might be a starting point. Happy to chat more if you’re interested!

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excellent, thanks for this

update, brief letter " Evolving Use of Real-World Evidence for Devices: Good for Patients, Good for Policy Makers" value in health journal