大型随机临床试验的监测:使用贝叶斯方法的新方法
M K Parmar1, G O Griffiths, D J Spiegelhalter
1Cancer Division, MRC Clinical Trials Unit, 222 Euston Road, NW1 2DA, London, UK.
Lancet (London, England)
|August 15, 2001
概括
对临床试验监测的贝叶斯方法被证明是有价值的,在p值可能建议早期关闭时,试验保持开放. 这种方法为数据监控和道德委员会提供了一个更直观的替代方案.
科学领域:
- 临床试验 临床试验
- 医学统计 医学统计
- 在瘤学瘤学.
背景情况:
- 数据监测和伦理委员会 (DMEC) 通常使用p值来指导在随机临床试验中继续招募患者的决策.
- 贝叶斯方法用于监测20世纪90年代肺癌和头癌患者的两项随机对照试验.
研究的目的:
- 评估贝叶斯方法在随机临床试验监测中的实用性,与传统的基于p值的方法相比.
- 评估贝叶斯监测如何影响有关继续试验和提前结束试验的决定.
主要方法:
- 临床医生对治疗疗效的先前信念在试验开始前被正式化为"热情"和"怀疑"的先前分配.
- 这些先前的分布每年都用试验数据更新,DMEC决定结果是否可以说服怀疑论者或热情人士.
主要成果:
- DMECs始终发现没有足够的证据来提前停止这两项试验,无论结果是否有利于研究治疗 (连续高分离加速放射治疗[CHART]) 或没有显示差异.
- 根据贝叶斯监测方法,这两项试验都没有过早结束.
- 如果采用传统的基于p值的停止规则,肺癌试验可能会提前停止.
结论:
- 对临床试验监测的贝叶斯式方法很简单,易于实施,易于DMEC成员理解.
- 这种方法被认为比传统的基于p值的监测策略更具直观吸引力.
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