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

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