Group sequential designs using Lan-DeMets error spending functions are proposed for historical control trials with time-to-event endpoints. Both O'Brien-Fleming and Gamma family types of sequential decision boundaries are derived based on sequential log-rank tests, which follow a Brownian motion in a transformed information time. Simulation results show that the proposed group sequential designs using historical controls preserve the overall type I error and power.

中文翻译：

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使用错误支出功能对历史控制试验进行分组顺序设计。

提出了使用Lan-DeMets错误支出函数的组顺序设计，用于具有事件发生时间终点的历史控制试验。顺序决策边界的O'Brien-Fleming和Gamma族类型都是基于顺序对数秩检验得出的，该序列在变换的信息时间内遵循布朗运动。仿真结果表明，所提出的使用历史控件的组顺序设计保留了总体I类错误和功耗。