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9 p, 1.7 MB Inclusion of non-inferiority analysis in superiority-based clinical trials with single-arm, two-stage Simon's design / Sampayo-Cordero, Miguel (Medica Scientia Innovation Research (MedSIR)) ; Miguel-Huguet, Bernat (Hospital Universitari de Bellvitge) ; Pérez-García, José (QuironSalud Group) ; Páez, David (Institut d'Investigació Biomèdica Sant Pau) ; Guerrero-Zotano, Ángel L. (Vanderbilt University Medical Center) ; Garde-Noguera, Javier (Hospital Arnau de Vilanova (Lleida, Catalunya)) ; Aguirre, Elena (Hospital Quirónsalud Zaragoza) ; Holgado, Esther (Hospital Universitario Ramón y Cajal (Madrid)) ; López-Miranda, Elena (Hospital Universitario Ramón y Cajal (Madrid)) ; Huang, Xin (Pfizer Global Research and Development) ; Malfettone, Andrea (Medica Scientia Innovation Research (MedSIR)) ; Llombart-Cussac, Antonio (Hospital Arnau de Vilanova (Lleida, Catalunya)) ; Cortés, Javier (Vall d'Hebron Institut d'Oncologia) ; Universitat Autònoma de Barcelona
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. [...]
2020 - 10.1016/j.conctc.2020.100678
Contemporary Clinical Trials Communications, Vol. 20 (november 2020)  

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