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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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出版年: | Contemp Clin Trials Commun |
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主要な著者: | , , , , , , , , , , , , |
フォーマット: | Artigo |
言語: | Inglês |
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Elsevier
2020
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主題: | |
オンライン・アクセス: | 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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