Xiong Xiaoping, Wu Jianrong
Department of Biostatistics, St. Jude Children's Research Hospital, 262 Danny Thomas Place, Memphis, TN 38105, USA.
Pharm Stat. 2017 Jan;16(1):87-94. doi: 10.1002/pst.1790. Epub 2016 Nov 8.
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.
近几十年来,癌症治疗取得了显著进展,以至于在相当比例的各类癌症患者中看到治愈或长期生存已不再罕见。为了在设计临床试验时充分考虑治愈比例,应使用治愈模型。在本文中,在比例风险治愈模型的固定备择假设下,推导了加权对数秩检验的样本量公式。模拟表明,所提出的样本量公式为在比例风险治愈模型下设计临床试验提供了准确的样本量估计。