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.
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In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do more to publicize the experience to date with RWE in regulatory submissions.
New draft guidance offers recommendations for translating real-world data from claims or EHR sources to meet FDA data requirements.
Demonstrating that electronic health record and medical claims datasets are fit for purpose, and addressing potential limitations in advance, are key themes of new draft guidance.