Early selection in a randomized phase II clinical trial
Early selection in a randomized phase II clinical trial
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DOI：
10.1002/sim.1150
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发表时间：
2002-06-30
影响因子：
2
通讯作者：
Venzon, DJ
中科院分区：
文献类型：
--
作者：
Steinberg, SM;Venzon, DJ
当一个人希望能够从几种类似疗法或一种疗法的变种中选择一种以包括在随后的最终的III期试验中时，可以采用随机的II期临床试验设计。在这种类型的试验中，没有必要使用通常的参数和用于假设检验的严格标准来正式确定上臂。Simon、Wittes和Ellenberg描述了从k个可能的手臂中选择上臂的方法和样本大小。在这篇文章中，我们描述了一种基于统计选择理论的方法，该方法允许一个人潜在地做出决定，在试验的中间点结束随机第二阶段试验的应计费用，并在随后的研究中选择两个值得进一步评估的药物之一。该方法要求在过渡点观察到两个臂之间的响应数量的足够差距，以便限制所选择的ANN实际上低于无差别数量的概率。2002年由John Wiley Sons，Ltd.出版。
A randomized phase II clinical trial design can be employed when one wishes to be able to select one of several similar therapies or variants of a therapy for inclusion in a subsequent, definitive, phase III trial. It is not necessary in this type of trial to formally identify a superior arm using the usual parameters and stringent criteria employed for hypothesis testing. Simon, Wittes and Ellenberg have described methods and sample sizes for selecting the superior arm from among k possible arms. In this paper, we describe an approach based on statistical selection theory which allows one to potentially make a decision to end accrual to a randomized phase II trial at an interim point of the trial, and to select one of two arms as being worthy of further evaluation in a subsequent study. This method requires that an adequate gap in the number of responses between the two arms be observed at the interim point in order to limit the probability that the selected ann is actually inferior by more than an indifference amount. Published in 2002 by John Wiley Sons, Ltd.