Aligning on the advancement of real-world evidence
RWE Alliance members aim to provide a united voice on how regulators can deploy real-world evidence in decision-making
As FDA prepares to put a stake in the ground for how real-world evidence can be used in regulatory decision-making, executives from leading real-world data and analytics companies have highlighted the need for industry-wide standardization on the use of RWD and pointed to near-term opportunities for making real-world evidence a routine part of the drug development and approval process.
Last week, five of the most prominent companies working in real-world evidence (RWE) — Aetion Inc., the Flatiron Health Inc. subsidiary of Roche (SIX:ROG; OTCQX:RHHBY), IQVia Holdings Inc. (NYSE:IQV), Syapse Inc. and Tempus Labs Inc. — launched the RWE Alliance to advance the use of RWE, just a few months before FDA is expected to publish new guidance on how RWE can be used to support regulatory decision-making...