Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial.
Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial.
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使用二分法生存数据来构建贝叶斯无缝II/III期临床试验的先前分布。
DOI：
10.1177/09622802231160554
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发表时间：
2023-05
影响因子：
2.3
通讯作者：
Ursino, Moreno
中科院分区：
文献类型：
--
作者：
Duputel, Benjamin;Stallard, Nigel;Montestruc, Francois;Zohar, Sarah;Ursino, Moreno
主方案设计允许同时比较多个治疗或疾病亚组。MASTER方案也可以设计为无缝研究，在同一试验中考虑两个或更多临床阶段。它们可以分为两类：操作上无缝的，其中两个阶段被分成两个独立的研究；推理上无缝的，其中中期分析被认为是研究的改编。贝叶斯设计很少被研究。我们的目标是提出和比较贝叶斯操作无缝的第二/第三阶段设计，第一阶段使用二进制端点，第二阶段使用事件间隔时间端点。在第二阶段结束时，ARM选择基于后验(无效)和预测(选择)概率。然后，第一阶段的结果被合并到事件时间模型的先前分布中。仿真研究表明，贝叶斯操作无缝设计可以接近推理无缝设计，允许相对于操作频率设计增加模拟功率。
Master protocol designs allow for simultaneous comparison of multiple treatments or disease subgroups. Master protocols can also be designed as seamless studies, in which two or more clinical phases are considered within the same trial. They can be divided into two categories: operationally seamless, in which the two phases are separated into two independent studies, and inferentially seamless, in which the interim analysis is considered an adaptation of the study. Bayesian designs are scarcely studied. Our aim is to propose and compare Bayesian operationally seamless Phase II/III designs using a binary endpoint for the first stage and a time-to-event endpoint for the second stage. At the end of Phase II, arm selection is based on posterior (futility) and predictive (selection) probabilities. The results of the first phase are then incorporated into prior distributions of a time-to-event model. Simulation studies showed that Bayesian operationally seamless designs can approach the inferentially seamless counterpart, allowing for an increasing simulated power with respect to the operationally frequentist design.
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影响因子：
1.9
作者：
FLEMING, TR
通讯作者：
FLEMING, TR
影响因子：
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作者：
Chang, Sean;Berger, James O.
通讯作者：
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DOI：
10.1080/03610926.2019.1618871
发表时间：
2019-05-27
影响因子：
0.8
作者：
Quan, Hui;Luo, Xiaodong;Zhao, Peng-Liang
通讯作者：
Zhao, Peng-Liang
影响因子：
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作者：
Stallard, Nigel
通讯作者：
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