title: Testing of non-inferiority and superiority for three-arm clinical studies with multiple experimental treatments.
abstract: The purpose of a non-inferiority trial is to assert the efficacy of an experimental treatment compared with a reference treatment by showing that the experimental treatment retains a substantial proportion of the efficacy of the reference treatment. Statistical methods have been developed to test multiple experimental treatments in three-arm non-inferiority trials. In this paper, we report the development of procedures that simultaneously test the non-inferiority and the superiority of experimental treatments after the assay sensitivity has been established. The advantage of the proposed test procedures is the additional ability to identify superior treatments while retaining an non-inferiority testing power comparable to that of existing testing procedures. Single-step and stepwise procedures are derived and then compared with each other to determine their relative testing power and testing error in a simulation study. Finally, the suggested procedures are illustrated with two clinical examples.
authors.affiliation: 1 School of Applied Mathematics, Xiamen University of Technology, Xiamen, China.|2 Department of Statistics, National Cheng Kung University, Tainan, Taiwan.
authors.forename: Junjiang
authors.initials: J
authors.lastname: Zhong
authors.affiliation: 2 Department of Statistics, National Cheng Kung University, Tainan, Taiwan.
authors.forename: Miin-Jye
authors.initials: MJ
authors.lastname: Wen
authors.affiliation: 3 School of Economics, Singapore Management University, Singapore, Singapore.
authors.forename: Koon Shing
authors.initials: KS
authors.lastname: Kwong
authors.affiliation: 2 Department of Statistics, National Cheng Kung University, Tainan, Taiwan.|4 Department of Statistics, The Chinese University of Hong Kong, Shatin, Hong Kong, China.
authors.forename: Siu Hung
authors.initials: SH
authors.lastname: Cheung
mesh_terms: D000465:Algorithms; D000068456:Clinical Studies as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D006801:Humans; D035703:Therapies, Investigational / Q000592:standards* / Q000706:statistics & numerical data
keywords: Non-inferiority; assay sensitivity; familywise error rate; superiority; three-arm trial