Real-World Evidence More Helpful To US FDA In Cases Of High Clinical Trial Efficacy

Pfizer-funded systematic review of approved oncology applications that contained RWE highlights common deficiencies flagged by FDA and says strength of trial data is a key determinant of the extent to which RWE is needed and considered by the agency.

Red flag
A new study describes FDA red flags in oncology drug applications containing real-world evidence. • Source: Alamy

The extent of the US Food and Drug Administration’s criticism of real-world evidence in oncology drug applications appears inversely correlated with the efficacy seen in the pivotal trial, researchers said in a Pfizer Inc.-funded study in the journal Clinical Cancer Research.

For pivotal trials with a high overall response rate, there was less criticism by the FDA on the quality of the RWE submitted as supportive evidence, said Pfizer’s Bhakti Arondeker, lead author with colleagues from the pharma company as well as

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