Open AccessEvolving use of real-world evidence in the regulatory process: a focus on immuno-oncology treatment and outcomes
Author(s) -
John C. O’Donnell,
Trong Kim Le,
Radu Dobrin,
Mitch Higashi,
Ashley Pereira,
Samuel Wagner,
Allison Yang,
Mathias Hukkelhoven
Publication year - 2021
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon-2020-0591
Subject(s) - medicine , context (archaeology) , regulatory science , clinical trial , drug development , real world evidence , drug approval , drug , pharmacology , pathology , paleontology , biology
In recent years, regulatory bodies have increasingly recognized the utility of real-world evidence (RWE) for supplementing and supporting clinical trial data in new drug applications. Nevertheless, the integration of RWE into established regulatory processes is complex and the generation of ‘regulatory-grade’ real-world data faces operational, methodological, data-related and policy-related challenges. In parallel with this evolving role for RWE, immuno-oncology therapies have emerged as leading cancer treatments and are expected to continue to play a central role in the future. In this article, we review the current literature on the use of RWE for regulatory submissions, with a focus on novel anticancer immunotherapies, and discuss the utility and current limitations of RWE in the context of drug development and regulatory approvals.