On Wednesday, five health data analytics companies announced they have banded together to form an industry consortium that aims to transform the way new drugs and devices make their way to patients.
The digitization of medical records has opened up access to reams of data about patient outcomes in the past decade, but not all of it has found a use. “Real-world data, in and of itself, is not that interesting, right?” said Michael Vasconcelles, chief medical officer of Flatiron Health, the initiator of the new alliance. “It’s really the insights that one gleans from asking important scientific questions that then can be answered or informed by those data.” In other words, maybe that data can grow up to become real-world evidence, or RWE.
The RWE Alliance — whose founding members include Flatiron Health, Aetion, IQVIA, Syapse, and Tempus — has assembled to advance the deployment of real-world data in the Food and Drug Administration’s regulatory decisions. By complementing evidence from traditional clinical trials, RWE could potentially speed the approval process for new drug indications and lower the costs of post-approval studies.
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