An adaptive dose-finding approach for correlated bivariate binary and continuous outcomes in phase I oncology trials
An adaptive dose-finding approach for correlated bivariate binary and continuous outcomes in phase I oncology trials
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DOI：
10.1002/sim.4425
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发表时间：
2012-03-15
影响因子：
2
通讯作者：
Hirakawa, Akihiro
中科院分区：
文献类型：
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作者：
Hirakawa, Akihiro
在这项研究中，我们开发了一种新的自适应剂量发现方法，用于在设计I期肿瘤学试验时纳入相关的双变量二元和连续结局。对于这种方法，二元毒性和连续有效性结局与因子分解模型联合建模。所提出的方法的基本策略主要是基于贝叶斯方法。我们根据毒性和疗效结局的后验分布制定剂量递增/递减决策规则。我们比较了建议和现有的方法，通过模拟研究在各种情况下的操作特性。结果表明，当真实推荐剂量相对处于试验剂量的尾端时，该方法的真实推荐剂量推荐率优于现有方法。当真实RD相对位于最上端时，与现有方法相似。版权所有（c）2011约翰威利父子有限公司
In this study, we developed a novel adaptive dose-finding approach for inclusion of correlated bivariate binary and continuous outcomes in designing phase I oncology trials. For this approach, binary toxicity and continuous efficacy outcomes are modeled jointly with a factorization model. The basic strategy of the proposed approach is based primarily on the Bayesian method. We based the dose escalation/de-escalation decision rules on the posterior distributions of both toxicity and efficacy outcomes. We compared the operating characteristics of the proposed and existing methods through simulation studies under various scenarios. We found that the recommendation rate of the true recommended dose (RD) in the proposed method was more favorable than that in the existing method when the true RD was relatively at the tail end among the tested doses. It was similar to that of the existing method when the true RD was relatively at the top end. Copyright (c) 2011 John Wiley & Sons, Ltd.