Practical guidelines for multiplicity adjustment in clinical trials
Practical guidelines for multiplicity adjustment in clinical trials
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DOI：
10.1016/s0197-2456(00)00106-9
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发表时间：
2000-12-01
期刊：
影响因子：
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通讯作者：
Waclawiw, MA
中科院分区：
文献类型：
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作者：
Proschan, MA;Waclawiw, MA
临床试验中的多重性可能以几种不同的形式出现：多个终点、多个治疗组比较和中期监测期间对数据的多次观察，仅举几例。统计学家和非统计学家都认识到，多重性增加了实验的第一类错误率，这促使了许多多重比较调整程序的发展。在今天的临床试验者中，仍然存在着一个更棘手、更有争议的争论点，那就是围绕着临床试验中多重性调整的必要性的哲学。本文件就如何以务实的方式处理这一复杂问题提供了指导方针。通过一系列的场景和例子，我们说明了围绕多重性概念的基本问题，并指出了在审议多重比较调整的必要性和程度时应该问的一些关键问题。(C)Elsevier Science Inc. 2000.
Multiplicity in clinical trials may appear under several different guises: multiple endpoints, multiple treatment arm comparisons, and multiple looks at the data during interim monitoring, to name a few. It is well recognized by statisticians and nonstatisticians alike that multiplicity inflates the type I error rate of the experiment, and this has prompted the development of many multiple comparison adjustment procedures. What has remained one of the thornier and more controversial points of contention among trialists today is the philosophy surrounding the need for multiplicity adjustment in clinical trials. This paper provides guidelines on how to deal with this complex issue in a practical manner. Through a series of scenarios and examples, we illustrate the fundamental issues surrounding the concept of multiplicity and point to some key questions one should ask when deliberating on the necessity and extent of adjustment for multiple comparisons. (C) Elsevier Science Inc. 2000.