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使用贝叶斯等级建模用于临床试验绩效评估,用于癌症中心的临床试验积累
Xiaosong Shi1,2, Dinesh Pal Mudaranthakam1,2, Jo A Wick1,2
1Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, KS, USA.
Contemporary clinical trials communications
|February 29, 2024
概括
实施精选癌症临床结果数据库 (C3OD) 改善了堪萨斯大学综合癌症中心的癌症临床试验积累性能. 贝叶斯模型评估了试验绩效,考虑到COVID-19大流行的影响.
科学领域:
- 临床研究行动临床研究行动.
- 生物统计学 生物统计学
- 癌症研究 癌症研究
背景情况:
- 癌症临床试验中的患者积累速度缓慢是一个重大挑战.
- 堪萨斯大学综合癌症中心 (KUCC) 在2021年实施了策划癌症临床结果数据库 (C3OD),以加强试验可行性分析.
- 实时电子病历数据对于准确的试验绩效评估至关重要.
研究的目的:
- 提出和评估贝叶斯的等级模型来评估癌症临床试验的年度累计绩效.
- 量化C3OD实施和COVID-19大流行对试验积累的影响.
- 建立一个可靠的监测临床试验积累率的方法.
主要方法:
- 一个贝叶斯层次模型,使用波松分布来建模个体试验积累.
- 纳入一个层次组件来捕捉跨研究的绩效变化.
- 作为主要绩效指标,计算观察到和目标积累率的比率.
主要成果:
- 从2018年到2023年,KUCC的年度累计业绩呈现波动,2020年至2021年由于COVID-19大流行而出现显著下降.
- 该模型表明,与疫情前水平相比,C3OD在2023年提高了积累绩效的后期概率为0.935,与C3OD相比,C3OD的后期概率为0.935.
- 敏感性分析证实了该模型在评估积累性绩效方面的稳定性.
结论:
- C3OD的实施已经证明对KUCC的癌症临床试验积累产生了积极和持续的影响.
- 虽然COVID-19大流行显著但暂时影响了试验累计表现.
- 使用强大的统计模型对临床试验累计绩效的持续评估对于癌症中心至关重要.
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