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Lookup NU author(s): Professor James WasonORCiD
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© 2024 Elsevier LtdDrug development has historically relied on phase I–III clinical trials including participants sharing the same disease. However, drug development has evolved as the discovery of mechanistic drivers of disease demonstrated that the same therapeutic target may provide benefits across different diseases. A basket trial condenses evaluation of one therapy among multiple related diseases into a single trial and presents an opportunity to borrow information across them rather than viewing each in isolation. Borrowing is a statistical tool but requires a foundation of clinical and therapeutic mechanistic justification. We review the Bayesian borrowing approach, including its assumptions, and provide a framework for how this approach can be evaluated for successful use in a basket trial for drug development.
Author(s): Broglio KR, Blau JE, Pilling EA, Wason JMS
Publication type: Review
Publication status: Published
Journal: Drug Discovery Today
Year: 2024
Volume: 29
Issue: 9
Print publication date: 01/09/2024
Online publication date: 02/08/2024
Acceptance date: 02/04/2024
ISSN (print): 1359-6446
ISSN (electronic): 1878-5832
Publisher: Elsevier Ltd
URL: https://doi.org/10.1016/j.drudis.2024.104127
DOI: 10.1016/j.drudis.2024.104127
PubMed id: 39098385