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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Bibliographic Details
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
Format:	Artigo
Language:	Inglês
Published:	BioMed Central 2013
Subjects:	Research Article
Online Access:	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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Phase IV non-inferiority trials and additional claims of benefit

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