Through the Looking Glass: Understanding Non-Inferiority

Trials. 2011 May 3;12:106. doi: 10.1186/1745-6215-12-106.

Abstract

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.

Publication types

  • Review

MeSH terms

  • Animals
  • Clinical Trials as Topic / legislation & jurisprudence
  • Clinical Trials as Topic / methods*
  • Device Approval
  • Drug Approval
  • Endpoint Determination
  • Europe
  • Evidence-Based Medicine / legislation & jurisprudence
  • Evidence-Based Medicine / methods*
  • Government Regulation
  • Humans
  • Research Design* / legislation & jurisprudence
  • Risk Assessment
  • Sample Size
  • Therapeutic Equivalency
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration