Choice of a non-inferiority margin - Scientific guideline

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.

Keywords: Confidence interval, non-inferiority margin, statistical significance level, active comparator, putative placebo, clinical relevance

Current effective version

Guideline on the choice of the non-inferiority margin

AdoptedLegal effective date: 01/01/2006Reference Number: EMEA/CPMP/EWP/2158/99