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A two-stage phase II clinical trial design with nested criteria for early stopping and efficacy

We propose a two-stage design for a single arm clinical trial with an early stopping rule for futility. This design employs different endpoints to assess early stopping and efficacy. The early stopping rule is based on a criteria determined more quickly than that for efficacy. These separate criteri...

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Detalhes bibliográficos
Publicado no:Pharm Stat
Main Authors: DeVeaux, Michelle, Kane, Michael, Wei, Wei, Zelterman, Daniel
Formato: Artigo
Idioma:Inglês
Publicado em: 2019
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6996237/
https://ncbi.nlm.nih.gov/pubmed/31507079
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pst.1965
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