title: A score test for establishing non-inferiority with respect to short-term survival in two-sample comparisons with identical proportions of long-term survivors.
abstract: In recent years randomized trials designed to establish non-inferiority of a new treatment as compared to a standard one have been more widely used. Two-sample statistics have been proposed for this equivalence testing problem. However, they are not suited to situations where a long-term survivor fraction is expected. In this paper we propose a score test designed for establishing non-inferiority for the new treatment as compared to the standard one while assuming identical long-term survivor rates. Simulations results show that the proposed statistic has satisfactory size and power as long as certain restricting conditions are verified. A breast cancer trial is analysed as an example.
authors.affiliation: Faculté de Médecine Paris-Sud and INSERM U472, 16 Avenue P. Vaillant-Couturier, 94807 Villejuif, France.
authors.forename: P
authors.initials: P
authors.lastname: Broët
authors.forename: P
authors.initials: P
authors.lastname: Tubert-Bitter
authors.forename: Y
authors.initials: Y
authors.lastname: De Rycke
authors.forename: T
authors.initials: T
authors.lastname: Moreau
mesh_terms: D001943:Breast Neoplasms / Q000532:radiotherapy / Q000601:surgery; D003198:Computer Simulation; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000601:surgery; D008954:Models, Biological; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D016019:Survival Analysis; D013810:Therapeutic Equivalency