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Through the looking glass: understanding non-inferiority Schumi J; Wittes JTTrials 2011[May]; 12 (ä): 106Non-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.|*Research Design/legislation & jurisprudence[MESH]|Animals[MESH]|Clinical Trials as Topic/legislation & jurisprudence/*methods[MESH]|Device Approval[MESH]|Drug Approval[MESH]|Endpoint Determination[MESH]|Europe[MESH]|Evidence-Based Medicine/legislation & jurisprudence/*methods[MESH]|Government Regulation[MESH]|Humans[MESH]|Risk Assessment[MESH]|Sample Size[MESH]|Therapeutic Equivalency[MESH]|Treatment Outcome[MESH]|United States[MESH]|United States Food and Drug Administration[MESH] |
