title: A novel sample size formula for the weighted log-rank test under the proportional hazards cure model.
abstract: The treatment of cancer has progressed dramatically in recent decades, such that it is no longer uncommon to see a cure or log-term survival in a significant proportion of patients with various types of cancer. To adequately account for the cure fraction when designing clinical trials, the cure models should be used. In this article, a sample size formula for the weighted log-rank test is derived under the fixed alternative hypothesis for the proportional hazards cure models. Simulation showed that the proposed sample size formula provides an accurate estimation of sample size for designing clinical trials under the proportional hazards cure models.
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN 38105, USA.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Xiong
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN 38105, USA.
authors.forename: Jianrong
authors.initials: J
authors.lastname: Wu
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003198:Computer Simulation; D006801:Humans; D015233:Models, Statistical; D009369:Neoplasms / Q000628:therapy*; D016016:Proportional Hazards Models; D012107:Research Design; D018401:Sample Size; D016019:Survival Analysis
keywords: clinical trial; cure model; log-rank test; proportional hazards model; sample size calculation; survival analysis