Real-world evidence partisans now have data to fight about

For years, biopharmaceutical futurists have pointed to a day when so-called real-world evidence, culled from sources like health records and insurance claims, could replace the costly gold standard that is the randomized clinical trial, an idea that has raised the hackles of more than a few skeptics. Now, thanks to the FDA and a company called Aetion, the two sides have a pilot study to squabble over.

As STAT’s Matthew Herper reports, Aetion put its computational power to the test by trying to replicate a study comparing two diabetes treatments. The result, according to company co-founder Dr. Sebastian Schneeweiss of Brigham and Woman’s Hospital, was “quite an achievement,” one that “elevated the conversation from ‘real-world evidence is all bad’ to 'let’s have a differentiated conversation about this.’”

But outside experts took issue issue with the idea, questioning whether Aetion’s approach could ever be useful in reality. One even called the inaugural attempt “dangerous.”

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