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Exploring the statistical and clinical impact of two interim analyses on the phase II design with option for direct assignment

PURPOSE: The primary goal of Phase II clinical trials is to understand better a treatment’s safety and efficacy to inform a phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The phase II design wit...

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Detalhes bibliográficos
Main Authors: An, Ming-Wen, Mandrekar, Sumithra J., Edelman, Martin J., Sargent, Daniel J.
Formato: Artigo
Idioma:Inglês
Publicado em: 2014
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4104229/
https://ncbi.nlm.nih.gov/pubmed/24768938
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.cct.2014.04.007
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