Emulating Comparative Oncology Trials With Real-World Evidence Studies (ENCORE): Process Development and Methodological Considerations for Oncology Real-World Data.

Janick Weberpals¹, Sebastian Schneeweiss¹, Kenneth L Kehl², Donna R Rivera³, Pallavi Mishra-Kalyani³, Catherine C Lerro³, Erin Larkins⁴, Preeti Narayan⁴, Richard Curley³, Georg Hahn¹, Priyanka Anand¹, Yanina Natanzon⁵, Andrew J Belli⁶, Ching-Kun Wang⁶, Jenna Collins⁷, Jonathan Kish⁷, Janet Espirito⁸, Nicholas J Robert⁸, Robert J Glynn¹, Shirley V Wang¹

¹Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

²Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

³Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.

⁴Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

⁵ConcertAI, Cambridge, Massachusetts, USA.

⁶COTA, Inc., New York, New York, USA.

⁷Flatiron Health, Inc., New York, New York, USA.

⁸Ontada, Boston, Massachusetts, USA.

PubMed DOI

Abstract

Real-world evidence (RWE) is increasingly used to complement findings from randomized controlled trials (RCTs), contextualizing the effectiveness and safety of medical interventions as delivered in routine clinical practice. Advances in the curation and accessibility of electronic health record (EHR) data present the opportunity to utilize real-world data (RWD) to investigate therapeutic areas inc…

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