Bayesian adaptive phase II screening design for combination trials.
Bayesian adaptive phase II screening design for combination trials.
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DOI：
10.1177/1740774512470316
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Johnson VE
中科院分区：
文献类型：
--
作者：
Cai C;Yuan Y;Johnson VE
用于治疗癌症的联合疗法的试验在与这种疾病的斗争中发挥着越来越重要的作用。为了更有效地处理大量的联合治疗，必须进行测试，我们提出了一种新的贝叶斯II期自适应筛选设计，同时选择可能的治疗组合，涉及多种药物。我们的设计是基于将选择程序制定为贝叶斯假设检验问题，其中每种治疗组合的优效性等同于单一假设。在试验进行期间，我们使用所有假设的后验概率的当前值来自适应地将患者分配到治疗组合。仿真研究表明，所提出的设计大大优于传统的多臂平衡析因试验设计。所提出的设计产生了一个显着更高的概率选择最佳治疗，同时分配更多的患者有效的治疗。该设计最适合于多种药物联合试验，并筛选出有效的组合进行进一步研究。提出的贝叶斯自适应II期筛选设计大大优于传统的完全析因设计。我们的设计将更多的患者分配到更好的治疗，同时提供更高的把握度来确定试验结束时的最佳治疗。
Trials of combination therapies for the treatment of cancer are playing an increasingly important role in the battle against this disease. To more efficiently handle the large number of combination therapies that must be tested, we propose a novel Bayesian phase II adaptive screening design to simultaneously select among possible treatment combinations involving multiple agents. Our design is based on formulating the selection procedure as a Bayesian hypothesis testing problem in which the superiority of each treatment combination is equated to a single hypothesis. During the trial conduct, we use the current values of the posterior probabilities of all hypotheses to adaptively allocate patients to treatment combinations. Simulation studies show that the proposed design substantially outperforms the conventional multiarm balanced factorial trial design. The proposed design yields a significantly higher probability for selecting the best treatment while allocating substantially more patients to efficacious treatments. The proposed design is most appropriate for the trials combining multiple agents and screening out the efficacious combination to be further investigated. The proposed Bayesian adaptive phase II screening design substantially outperformed the conventional complete factorial design. Our design allocates more patients to better treatments while providing higher power to identify the best treatment at the end of the trial.
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