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

• Главные авторы: Raunak Dutta (Автор), Aparna Mohan (Автор), Jacqueline Buros‐Novik (Автор), Gregory Goldmacher (Автор), Omobolaji O. Akala (Автор), Brian Topp (Автор)
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• Опубликовано: Wiley, 2024-08-01T00:00:00Z.
• Предметы: article
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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...