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Some essential considerations in the design and conduct of non-inferiority trials

BACKGROUND: Suppose a standard therapy (Standard) has been established to provide a clinically important reduction in risk of irreversible morbidity or mortality. In that setting, the safety and efficacy of an experimental intervention likely would be assessed in a clinical trial providing a compari...

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Main Authors: Fleming, Thomas R, Odem-Davis, Katherine, Rothmann, Mark D, Shen, Yuan Li
Formato: Artigo
Idioma:Inglês
Publicado: 2011
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Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC3312046/
https://ncbi.nlm.nih.gov/pubmed/21835862
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1740774511410994
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