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The Impact of the Underlying Risk in Control Group and Effect Measures in Non-Inferiority Trials With Time-to-Event Data: A Simulation Study

BACKGROUND: We designed a simulation study to assess how the conclusions of a non-inferiority trial (NIT) will change if the observed risk is different from the expected risk. METHODS: We simulated Weibull distribution time-to-event data with a true hazard ratio (HR) being equal or close to 1. The e...

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Detalles Bibliográficos
Autores principales: Xie, Xuanqian, Ye, Chenglin, Mitsakakis, Nicholas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elmer Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5862084/
https://www.ncbi.nlm.nih.gov/pubmed/29581799
http://dx.doi.org/10.14740/jocmr3349e