Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development

Randomized controlled trials (RCTs) that assess overall survival are considered the “gold standard” when evaluating the efficacy and safety of a new oncology intervention. However, single-arm trials that use surrogate endpoints (e.g., objective response rate or duration of response) to evaluate clin...

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Bibliographic Details
Main Authors: Timothy A. Yap, Ira Jacobs, Elodie Baumfeld Andre, Lauren J. Lee, Darrin Beaupre, Laurent Azoulay
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-01-01
Series:Frontiers in Oncology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2021.695936/full