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