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

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
Main Authors: Miguel Sampayo-Cordero, Bernat Miguel-Huguet, José Pérez-García, David Páez, Ángel L. Guerrero-Zotano, Javier Garde-Noguera, Elena Aguirre, Esther Holgado, Elena López-Miranda, Xin Huang, Andrea Malfettone, Antonio Llombart-Cussac, Javier Cortés
Format: Article
Language:English
Published: Elsevier 2020-12-01
Series:Contemporary Clinical Trials Communications
Subjects:
Non-inferiority
Switching to non-inferiority
Two-stage
Single-arm
Phase II
Group sequential designs
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865420301629

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http://www.sciencedirect.com/science/article/pii/S2451865420301629

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