Choice of a non-inferiority margin
| Current effective version |
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| Reference number | CPMP/EWP/2158/99 |
| Published | 27/07/2005 |
| Effective from | 01/01/2006 |
| Keywords | Confidence interval, non-inferiority margin, statistical significance level, active comparator, putative placebo, clinical relevance |
| Description | This 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. |
