使用贝叶斯方法评估药物疗效的2期和3期随机对照试验中的先验和决策值:系统性审查
Lorraine Barret1, Léa Liaigre1, Alex Hlavaty2
1University Grenoble Alpes, Inserm, CHU Grenoble Alpes, CIC 1406, Grenoble 38000, France.
Journal of clinical epidemiology
|December 26, 2024
概括
药物疗效试验中的贝叶斯方法显示不一致的先验报告和决策值. 需要更明确的指导方针来对贝叶斯临床试验结果进行一致的解释和报告.
科学领域:
- 生物统计学 生物统计学
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 贝叶斯方法在临床试验中越来越多地用于药物疗效评估.
- 这些方法通过将先前的知识纳入统计分析来提供灵活性.
- 然而,由于缺乏标准化的报告,存在解释方面的挑战.
研究的目的:
- 系统地审查和描述2期和3期随机对照试验 (RCT) 中先验和决策值的应用,使用贝叶斯方法进行药物疗效评估.
- 识别临床研究中贝叶斯方法报告的当前做法和变化.
主要方法:
- 通过贝叶斯推理对第2期和第3期RCT进行了系统审查,通过贝叶斯推理评估药物疗效.
- 搜索的数据库包括到2022年9月的MEDLINE,EMBASE和Cochrane.
- 提取的数据集中在先前的类型,参数,理由,敏感性分析以及先验决策值的存在和值.
主要成果:
- 在1161篇选的文章中,包括69项试验 (91项比较).
- 在51%的病例中,先验被分配给治疗效应,在37%的病例中,被分配给每只手臂;在59%的病例中,先验分布的细节被提供.
- 在68%的研究中,事先定义了一个决策值,值在70%至99% (中位数95%) 之间.
结论:
- 对先验的不一致描述和对决策值的异构使用凸显了对标准化指南的需求.
- 对于在临床试验中应用和报告贝叶斯方法的更明确的标准是必不可少的.
- 报告贝叶斯试验结果需要提高透明度和一致性.
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