Choice of a non-inferiority margin

Current effective version

PDF icon Adopted guideline

Reference numberCPMP/EWP/2158/99
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.

Related content


How useful was this page?

Add your rating
1 rating