A bootstrapping method to optimize go/no‐go decisions from single‐arm, signal‐finding studies in oncology

Abstract Phase Ib trials are common in oncology development but often are not powered for statistical significance. Go/no‐go decisions are largely driven by observed trends in response data. We applied a bootstrapping method to systematically compare tumor dynamic end points to historical control da...

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Bibliographic Details
Main Authors: Raunak Dutta, Aparna Mohan, Jacqueline Buros‐Novik, Gregory Goldmacher, Omobolaji O. Akala, Brian Topp
Format: Article
Language:English
Published: Wiley 2024-08-01
Series:CPT: Pharmacometrics & Systems Pharmacology
Online Access:https://doi.org/10.1002/psp4.13161
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