title: Simultaneous group sequential analysis of rank-based and weighted Kaplan-Meier tests for paired censored survival data.
abstract: This research sequentially monitors paired survival differences using a new class of nonparametric tests based on functionals of standardized paired weighted log-rank (PWLR) and standardized paired weighted Kaplan-Meier (PWKM) tests. During a trial, these tests may alternately assume the role of the more extreme statistic. By monitoring PEMAX, the maximum between the absolute values of the standardized PWLR and PWKM, one combines advantages of rank-based (RB) and non-RB paired testing paradigms. Simulations show that monitoring treatment differences using PEMAX maintains type I error and is nearly as powerful as using the more advantageous of the two tests in proportional hazards (PH) as well as non-PH situations. Hence, PEMAX preserves power more robustly than individually monitored PWLR and PWKM, while maintaining a reasonably simple approach to design and analysis of results. An example from the Early Treatment Diabetic Retinopathy Study (ETDRS) is given.
authors.affiliation: Department of Biostatistics, University of Michigan, 1420 Washington Heights, Ann Arbor, Michigan 48109, USA. andreia@umich.edu
authors.forename: Adin-Cristian
authors.initials: AC
authors.lastname: Andrei
authors.forename: Susan
authors.initials: S
authors.lastname: Murray
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000494:pharmacology; D001241:Aspirin / Q000494:pharmacology; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D003930:Diabetic Retinopathy / Q000517:prevention & control; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D016019:Survival Analysis; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D001241:Aspirin