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US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

 
• By Michael Cipriano

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

Patient medical record browse on tablet in someone hand on white background.
US FDA's Bob Temple is skeptical about making effectiveness claims with real-world evidence.

US Food and Drug Administration officials have been enthusiastic, but cautious, about the prospects of using real-world evidence (RWE) to support new claims of efficacy. But Robert Temple, deputy director for clinical science in the Center for Drug Evaluation and Research (CDER), offered an especially pessimistic assessment of the concept.

"I find the whole thing very frustrating," Temple said during a 7 October FDA panel discussion at the Biopharma Congress.

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