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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The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions
Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.
RWE’s Biggest Role In US FDA Approvals: External Controls For Breakthrough Rare Disease Therapies
Despite broad interest, real-world evidence of efficacy in FDA decisions remains largely limited to orphan diseases and natural history, a Pink Sheet analysis shows.
Real-World Evidence: US FDA Urged To Leverage Prior Validation Work and Regulatory Experience
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.