Phase IV non-inferiority trials and additional claims of benefit

BACKGROUND: Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relev...

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Detalhes bibliográficos
Main Authors: Bernabe, Rosemarie DLC, Wangge, Grace, Knol, Mirjam J, Klungel, Olaf H, van Delden, Johannes JM, de Boer, Anthonius, Hoes, Arno W, Raaijmakers, Jan AM, van Thiel, Ghislaine JMW
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2013
Assuntos:
Research Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3679839/
https://ncbi.nlm.nih.gov/pubmed/23721202
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1471-2288-13-70
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