title: Why non-inferiority is more challenging than superiority?
abstract: Demonstrating non-inferiority in clinical trials is usually more challenging than showing superiority. In multiple sclerosis (MS), non-inferiority trials are rarely designed since they would require prohibitive sample sizes. In this brief report, the reasons why non-inferiority trials are usually larger than superiority trials is explored.
authors.affiliation: Biostatistics Unit, Department of Health Sciences (DISSAL), University of Genoa, Genova, Italy.
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Sormani
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D009103:Multiple Sclerosis / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000592:standards*; D012107:Research Design / Q000592:standards*
keywords: Multiple sclerosis; clinical trials; non-inferiority