Through the looking glass: understanding non-inferiority

Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.

Bibliographic Details
Main Authors: Schumi, Jennifer, Wittes, Janet T
Format: Online
Language:English
Published: BioMed Central 2011
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113981/