Designing complex group sequential survival trials
Designing complex group sequential survival trials
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DOI：
10.1002/sim.1193
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发表时间：
2002-07-30
影响因子：
2
通讯作者：
Lakatos, E
中科院分区：
文献类型：
--
作者：
Lakatos, E
本文提出了设计复杂组序贯生存试验的方法，当使用对数统计比较生存曲线时。该方法可以应用于任何治疗和对照生存曲线，只要每个风险函数可以通过分段线性函数来近似即可。该方法允许任意的应计模式，并允许对不同的不合规率、中断率和后续丢失率进行调整。日历-时间-信息-时间变换是在这些复杂的假设下导出的。这允许探索各种中期分析计划的操作特征，包括样本大小和功效。通过使用日历-时间-信息-时间变换，可以确定对应于期望的日历时间的信息部分。这样，可以在信息时间内安排中期分析，确保所需的功率和支出功能的实现，同时中期分析将根据所需的日历安排进行。版权所有 (C) 2002 John Wiley Sons, Ltd.
This paper presents methodology for designing complex group sequential survival trials when the survival curves will be compared using the logrank statistic. The method can be applied to any treatment and control survival curves as long as each hazard function can be approximated by a piecewise linear function. The approach allows arbitrary accrual patterns and permits adjustment for varying rates of noncompliance, drop-in and loss to follow-up. The calendar-time-information-time transformation is derived under these complex assumptions. This permits the exploration of the operating characteristics of various interim analysis plans, including sample size and power. By using the calendar-time-information-time transformation, information fractions corresponding to desired calendar times can be determined. In this way, the interim analyses can be scheduled in information time, assuring the desired power and realization of the spending function, while the interim analyses will take place according to the desired calendar schedule. Copyright (C) 2002 John Wiley Sons, Ltd.