Choice of a non-inferiority margin

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Current effective version

Adopted guideline

Reference numberCPMP/EWP/2158/99
Published27/07/2005
Effective from01/01/2006
KeywordsConfidence interval, non-inferiority margin, statistical significance level, active comparator, putative placebo, clinical relevance
DescriptionThis document provides guidance on two types of non-inferiority trials: trials with two arms, the test product and a comparator; and three-armed trials with the test product, an active comparator and placebo.


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