title: On a class of optimal covariate-adjusted response adaptive designs for survival outcomes.
abstract: A class of optimal covariate-adjusted response adaptive procedures is developed for phase III clinical trials when the treatment response is a survival time and there is random censoring. The basic aim is to develop an allocation design by combining the ethical aspects with statistical precision in a reasonable way under the presence of covariate information. Considering minimisation of total hazards as the ethical requirement, the proposed procedure is assessed in terms of the assignment to the better treatment and the efficiency (i.e. power) to detect a small departure in treatment effectiveness. The applicability of the proposed methodology is also illustrated using a real data set.
authors.affiliation: Applied Statistics Unit, Indian Statistical Institute, India atanu@isical.ac.in.
authors.forename: Atanu
authors.initials: A
authors.lastname: Biswas
authors.affiliation: Department of Statistics, University of Calcutta, India.
authors.forename: Rahul
authors.initials: R
authors.lastname: Bhattacharya
authors.affiliation: Department of Statistics, Chonnam National University, Korea.
authors.forename: Eunsik
authors.initials: E
authors.lastname: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D000741:Anemia, Aplastic / Q000601:surgery; D016026:Bone Marrow Transplantation; D002648:Child; D002675:Child, Preschool; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D016572:Cyclosporine / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006086:Graft vs Host Disease / Q000517:prevention & control; D006801:Humans; D007223:Infant; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000627:therapeutic use; D012107:Research Design; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016572:Cyclosporine; D008727:Methotrexate
keywords: clinical trials; covariate; ethics; optimality; survival data