INTERIM ANALYSIS - THE ALPHA-SPENDING FUNCTION-APPROACH
INTERIM ANALYSIS - THE ALPHA-SPENDING FUNCTION-APPROACH
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DOI：
10.1002/sim.4780131308
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发表时间：
1994-07-15
影响因子：
2
通讯作者：
LAN, KKG
中科院分区：
文献类型：
--
作者：
DEMETS, DL;LAN, KKG
由于伦理和科学的原因，对临床试验中积累的数据进行中期分析现在是一种既定的做法。如果处理不当，反复测试临时数据会增加误报错误率。群序列法是一种常用的频率学方法来控制错误率。受临床试验经验的启发，alpha花费函数是实现组顺序边界的一种方法，它可以控制第一类错误率，同时允许在进行多少次中期分析和在什么时间进行分析方面具有灵活性。在本文中，我们回顾了阿尔法花费函数方法，并详细说明了它在各种常用统计程序中的适用性，包括生存和纵向方法。
interim analysis of accumulating data in a clinical trial is now an established practice for ethical and scientific reasons. Repeatedly testing interim data can inflate false positive error rates if not handled appropriately. Group sequential methods are a commonly used frequentist approach to-control this error rate. Motivated by experience of clinical trials, the alpha spending function is one way to implement group sequential boundaries that control the type I error rate while allowing flexibility in how many interim analyses are to be conducted and at what times. In this paper, we review the alpha spending function approach, and detail its applicability to a variety of commonly used statistical procedures, including survival and longitudinal methods.