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ICPE All Access On Demand

Methods in Pharmacoepidemiology -> Study Design - Studies assessing study design (e.g., choice of comparator, self-controlled methods, avoiding immortal time bias)

Oral Papers

OR-5145 - Review Of Oncology Real-world Comparator Arm Submissions In Support Of Effectiveness Claims In 2019 Fda Original Approvals Reveals Label-grade Real-world Study Best Practices

ON DEMAND

Ilker Oztop, Wesley Eddings, Amanda Patrick, Pattra Mattox, Christina Purpura and Nicolle Gatto

Presenting Author(s)

Amanda R. Patrick, MS

MS
Aetion, Inc
Concord, Massachusetts, United States

Slides Slides and Audio

Co-Author(s)

Ilker Oztop, PhD

Director, Data Science Portfolio Management
Janssen Research & Development
Brooklyn, New York, United States

There is an increasing interest in the use of real world evidence (RWE) to generate external control arms (ECAs) to support regulatory submissions. Publicly-available FDA approval documents provide a valuable resource for understanding the criteria FDA is applying to RWE submissions. We present findings of our comprehensive review of 2019 oncology submissions that included RWE to support effectiveness or safety. We highlight methodological critiques raised by FDA and share the standards identifiable from this review.