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- W3093188829 abstract "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." @default.
- W3093188829 created "2020-10-22" @default.
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- W3093188829 date "2021-01-01" @default.
- W3093188829 modified "2023-10-17" @default.
- W3093188829 title "Evolving use of real-world evidence in the regulatory process: a focus on immuno-oncology treatment and outcomes" @default.
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- W3093188829 doi "https://doi.org/10.2217/fon-2020-0591" @default.
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