首席财务官:在临床试验中检测剂量的贝叶斯设计
Jialu Fang1, Ninghao Zhang1, Wenliang Wang1
1School of Computing and Data Science, The University of Hong Kong, Hong Kong, China.
JCO clinical cancer informatics
|January 31, 2025
概括
我们开发了用户友好的R和Shiny软件,用于在临床试验中实施先进的无校准赔率 (CFO) 类型设计. 这些工具通过整合随机化和各种CFO设计变体来提高剂量检测的准确性和效率.
科学领域:
- 生物统计学 生物统计学
- 临床试验设计 临床试验设计
- 药物指标 (Pharmacometrics) 是一个指标.
背景情况:
- 无校准概率 (CFO) 类型的设计是临床试验中可靠且无模型的剂量发现的当前标准.
- 对CFO类型设计的广泛采用的一个重要障碍是缺乏可访问的实施工具.
研究的目的:
- 开发用户友好的 R 包和 Shiny 基于网络的软件,用于实际实现 CFO 类型设计.
- 将随机化纳入CFO框架,创建随机化的CFO (rCFO) 设计.
主要方法:
- 开发了R包"CFO"和一个名为"CFO套件"的交互式R Shiny网络应用程序.
- 通过随机化整合了一个勘探开发机制,以引入rCFO设计.
- 嵌入了各种CFO设计变体,包括2dCFO,aCFO,TITE-CFO,fCFO,TITE-aCFO和分数-aCFO.
主要成果:
- 首席财务官包和首席财务官套件为各种临床试验设置提供了一个全面的工具套件.
- 提供了用于剂量确定,最大耐受剂量选择和通过模拟进行性能评估的功能.
- 输出包括模拟和试验结果的文字和图形表示.
结论:
- 首席财务官包和首席财务官套件为在I期临床试验中实施首席财务官类型设计提供了灵活和全面的工具.
- 这项工作整合了现有的CFO类型设计,使得新的试验设计能够提高性能.
- 该用户友好的软件促进了先进的统计方法的采用,并加强了生物统计学家和临床医生的合作,以提高试验的效率和准确性.
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