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Real-World Evidence: Sponsors Look To US FDA Drug Reviews For Potential Pitfalls

 
• By Sue Sutter

Methodological problems with RWE submissions for approved applications may give sponsors ‘a little bit of a pause’ as they work through data selection and analytical issues, Aetion’s Jeremy Rassen says. CDER’s Janet Woodcock says it is easier to use RWE when treatment effects are large.

Crystal_Ball
FDA review documents have become a crystal ball into the FDA's thinking on real-world evidence. • Source: Shutterstock

The US Food and Drug Administration’s publicly available reviews of real-world evidence submissions in approved drug applications may make other sponsors think twice about the types of data and analyses they submit to the agency.

Jeremy Rassen, president and chief science officer at the health care data analytics company Aetion, said that while he sees great excitement and interest among sponsors in using RWE and real-world data for regulatory purposes, he also sees some caution stemming from the FDA’s

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