title: Through the looking glass: understanding non-inferiority.
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.
authors.affiliation: Statistics Collaborative, Inc, Washington DC 20036, USA. jennifer@statcollab.com
authors.forename: Jennifer
authors.initials: J
authors.lastname: Schumi
authors.forename: Janet T
authors.initials: JT
authors.lastname: Wittes
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D018795:Device Approval; D017277:Drug Approval; D023381:Endpoint Determination; D005060:Europe; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence / Q000379:methods*; D033161:Government Regulation; D006801:Humans; D012107:Research Design / Q000331:legislation & jurisprudence; D018570:Risk Assessment; D018401:Sample Size; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration