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

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