Group sequential trials revisited: Simple implementation using SAS
Group sequential trials revisited: Simple implementation using SAS
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DOI：
10.1177/0962280210379036
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发表时间：
2011-12-01
影响因子：
2.3
通讯作者：
Whitehead, John
中科院分区：
文献类型：
--
作者：
Whitehead, John
分组序贯试验的方法现已确立并广泛实施。群体序贯方法的好处得到了普遍认可，当正确应用时，它的使用也被研究人员和监管者所接受。本文描述了如何使用两个可访问的SAS函数轻松实现广泛的组顺序设计。其中，PROBBNRM是一个标准函数，而另一个SEQ是SAS的交互矩阵语言proc IML的一部分。该书重点介绍了这种方法的要点，并揭示了它可以多么直截了当。描述了研究的设计，包括根据最终样本量的分布对研究进行评估。讨论了进行中期分析的情况，重点是不可避免地偏离计划的信息积累时间表的后果。考虑到顺序设计，最终分析所需的计算与在设计阶段进行的计算密切相关。文中给出了实例，并给出了适用的SAS代码清单。
The methodology of group sequential trials is now well established and widely implemented. The benefits of the group sequential approach are generally acknowledged, and its use, when applied properly, is accepted by researchers and regulators. This article describes how a wide range of group sequential designs can easily be implemented using two accessible SAS functions. One of these, PROBBNRM is a standard function, while the other, SEQ, is part of the interactive matrix language of SAS, PROC IML. The account focuses on the essentials of the approach and reveals how straightforward it can be. The design of studies is described, including their evaluation in terms of the distribution of final sample size. The conduct of the interim analyses is discussed, with emphasis on the consequences of inevitable departures from the planned schedule of information accrual. The computations required for the final analysis, allowing for the sequential design, are closely related to those conducted at the design stage. Illustrative examples are given and listings of suitable of SAS code are provided.