title: The pros and cons of noninferiority trials.
abstract: Noninferiority trials comparing new treatment with an active standard control are becoming increasingly common. This article discusses relevant issues regarding their need, design, analysis and interpretation: the appropriate choice of control group, types of noninferiority trial, ethical considerations, sample size determination and potential pitfalls to consider.
authors.affiliation: Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT UK. stuart.pocock@lshtm.ac.uk
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
mesh_terms: D002985:Clinical Protocols; D016001:Confidence Intervals; D018849:Controlled Clinical Trials as Topic / Q000941:ethics / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D026690:Ethics, Clinical; D006801:Humans; D010919:Placebos; D012107:Research Design; D018401:Sample Size
chemical_list: D010919:Placebos