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肝细胞癌辅助手术治疗III期随机对照试验的先验分布推导

Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma.

作者信息

Tan Say-Beng, Chung Y-F Alexander, Tai Bee-Choo, Cheung Yin-Bun, Machin David

机构信息

Division of Clinical Trials & Epidemiological Sciences, National Cancer Centre, Singapore, Singapore.

出版信息

Control Clin Trials. 2003 Apr;24(2):110-21. doi: 10.1016/s0197-2456(02)00318-5.

Abstract

A randomized, controlled clinical trial of radioactive iodine tagged with lipiodol in patients with resected hepatocellular carcinoma was criticized for its early stopping and resulting small sample size. To clarify its results, a new, larger multicenter trial was therefore proposed. This paper describes the elicitation of the pretrial opinions of the investigators involved in the new trial and the construction of appropriate clinical and skeptical prior distributions based on their responses. The prior distributions provide a useful tool in assessing the state of equipoise before the start of the trial. They can also be used in Bayesian analyses, both at the interim stage(s) as well as at the end of the trial. We illustrate these analyses, assuming that the data resulting from the new trial was the same as that obtained in the earlier trial when it was stopped.

摘要

一项关于碘化油标记放射性碘用于肝细胞癌切除术后患者的随机对照临床试验,因提前终止及样本量小而受到批评批评。为阐明其结果,因此提出了一项新的、规模更大的多中心试验。本文描述了参与新试验的研究人员的审前意见征集过程,以及根据他们的回答构建适当的临床和怀疑性先验分布。先验分布为评估试验开始前的平衡状态提供了一个有用的工具。它们也可用于贝叶斯分析,包括在试验的中期阶段以及试验结束时。我们举例说明这些分析,假设新试验产生的数据与早期试验停止时获得的数据相同。

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