Inclusion of non-inferiority analysis in superiority-based clinical trials with single-arm, two-stage Simon's design

INTRODUCTION: Non-inferiority (NI) analysis is not usually considered in the early phases of clinical development. In some negative phase II trials, a post-hoc NI analysis justified additional phase III trials that were successful. However, the risk of false positive achievements was not controlled...

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Bibliographic Details
Published in:Contemp Clin Trials Commun
Main Authors: Sampayo-Cordero, Miguel, Miguel-Huguet, Bernat, Pérez-García, José, Páez, David, Guerrero-Zotano, Ángel L., Garde-Noguera, Javier, Aguirre, Elena, Holgado, Esther, López-Miranda, Elena, Huang, Xin, Malfettone, Andrea, Llombart-Cussac, Antonio, Cortés, Javier
Format: Artigo
Language:Inglês
Published: Elsevier 2020
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Article
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC7733004/
https://ncbi.nlm.nih.gov/pubmed/33336109
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.conctc.2020.100678
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