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

• Main Authors: Raunak Dutta (Author), Aparna Mohan (Author), Jacqueline Buros‐Novik (Author), Gregory Goldmacher (Author), Omobolaji O. Akala (Author), Brian Topp (Author)
• Formato: Livro
• Publicado em: Wiley, 2024-08-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: Connect to this object online.

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...