The continual reassessment method for dose-finding studies: a tutorial
The continual reassessment method for dose-finding studies: a tutorial
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DOI：
10.1191/1740774506cn134oa
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发表时间：
2006-01-01
期刊：
影响因子：
2.7
通讯作者：
Garrett-Mayer, E
中科院分区：
文献类型：
--
作者：
Garrett-Mayer, E
连续再评估法（CRM），沿着与其他适应性剂量探索研究设计，自O'Quigley提出以来，已得到普及。它被临床试验者接受的几个原因是，与标准I期剂量递增设计相比，它倾向于引起更少的毒性事件，并且更准确地估计最大耐受剂量。在统计学文献中已经发表和讨论了许多变化，但是对于选择设计参数和实施CRM没有那么多实用的建议。因此，CRM尚未像其在剂量探索研究中那样广泛使用。本文的目的是为那些不熟悉CRM的人提供一个教程，他们要么是第一次考虑使用CRM的统计学家，要么是有一定统计背景的调查人员。本文介绍了原始CRM，然后它的一些修改版本。它还解释了定义CRM设计的规范，沿着CRM和标准设计的模拟示例，以供说明。
The Continual Reassessment Method (CRM), along with other adaptive dose-finding study designs, has gained popularity since its proposal by O'Quigley. Several of the reasons it has been embraced by clinical trialists is that it tends to incur fewer toxic events, and more accurately estimate the maximum tolerated dose as compared to the standard Phase I dose escalation designs. Many variations have been published and discussed in the statistical literature, but there has not been as much practical advice for choosing design parameters and implementing the CRM. As a result, the CRM has not been as widely utilized as it could be for dose-finding studies. The goal of this paper is to provide a tutorial for those unfamiliar with the CRM who are either statisticians considering using the CRM for the first time, or investigators with some statistical background. This paper presents the original CRM, and then some of its modified versions. It also explains the specifications that define a CRM design, along with simulated examples of CRMs and standard designs, for illustration.