The one-sample log-rank test is the method of choice for single-arm Phase II trials with time-to-event endpoint. It allows to compare the survival of the patients to a reference survival curve that typically represents the expected survival under standard of care. The classical one-sample log-rank test, however, assumes that the reference survival curve is deterministic. This ignores that the reference curve is commonly estimated from historic data and thus prone to statistical error. Ignoring sampling variability of the reference curve results in type I error rate inflation. For that reason, a new one-sample log-rank test is proposed that explicitly accounts for the statistical error made in the process of estimating the reference survival curve. The test statistic and its distributional properties are derived using martingale techniques in the large sample limit. In particular, a sample size formula is provided. Small sample properties regarding type I and type II error rate control are studied by simulation. A case study is conducted to study the influence of several design parameters of a single-armed trial on the inflation of the type I error rate when reference curve sampling variability is ignored.

翻译：一模版日志测试是单臂第二阶段试验的选择方法,有时间到活动末点。 它可以比较病人的存活率, 与通常代表护理标准下预期存活率的参考生存曲线进行比较。 但是,古典的一模版日志测试假定参考生存曲线是决定性的。 这忽略了参考曲线通常根据历史数据估计,从而容易发生统计错误。 忽略了参考曲线的抽样变异性, 忽略了参考曲线变异时单臂试验的若干设计参数对I型误差率通货膨胀的影响。