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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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| Publicado no: | Contemp Clin Trials Commun |
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| Main Authors: | , , , , , , , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Elsevier
2020
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| Assuntos: | |
| Acesso em linha: | 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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