A design for phase I trials in completely or partially ordered groups.

A design for phase I trials in completely or partially ordered groups.
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I阶段试验的设计完全或部分有序的组。

DOI:
10.1002/sim.7295
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发表时间:
2017-07-10
影响因子:
2
通讯作者:
Conaway MR
Conaway MR
中科院分区:
医学3区
文献类型:
--
作者:
Conaway MR

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我们提出了一种在完全或部分有序的患者组中发现细胞毒药物剂量的设计。所谓完全有序组,我们的意思是,在研究之前,有临床信息表明,对于给定的剂量,可以根据该剂量的毒性概率对组进行排序。对于部分排序的基团,在给定的剂量下,只有一些基团可以根据该剂量下的毒性概率进行排序。我们提出的方法包括了连续重评估方法中使用的参数模型的元素,并结合了Hwang-Peddada定阶估计过程。我们在一系列代表完整和部分顺序的剂量-毒性曲线中评估了这些设计的操作特征。
We propose a design for dose finding for cytotoxic agents in completely or partially ordered groups of patients. By completely ordered groups, we mean that prior to the study, there is clinical information that would indicate that for a given dose, the groups can be ordered with respect to the probability of toxicity at that dose. With partially ordered groups, at a given dose, only some of the groups can be ordered with respect to the probability of toxicity at that dose. The method we propose includes elements of the parametric model used in the continual reassessment method combined with the Hwang-Peddada order-restricted estimation procedure. We evaluate the operating characteristics of these designs in a family of dose–toxicity curves representing complete and partial orders.
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