| Autor: |
O'Donnell, John C, Le, T Kim, Dobrin, Radu, Higashi, Mitch, Pereira, Ashley, Wagner, Samuel, Yang, Arvin, Hukkelhoven, Mathias, Le, T Kim |
| Zdroj: |
Future Oncology; Jan2021, Vol. 17 Issue 3, p333-347, 15p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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