Choice of a non-inferiority margin

  • Email
  • Help
Current effective version

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 helpful is this page?

Average rating:

 Based on 30 ratings

Add your rating:

See all ratings
6 ratings
6 ratings
6 ratings
6 ratings
6 ratings

Tell us more