2对1随机化:很少建议使用
Boris Freidlin1, Edward L Korn1
1Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
JCO oncology practice
|July 10, 2024
概括
一些瘤学试验使用二比一随机化,将更多的患者分配给实验性治疗. 这篇评论质疑了这种常见的瘤学试验设计的假设有利的风险效益比率.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 随机临床试验 (RCT) 通常将相同的患者数量分配给治疗组.
- 一些瘤学试验因使用不平等的分配而偏离,例如二比一随机化,有利于实验臂.
研究的目的:
- 审查瘤学试验中二比一随机化的常见理由.
- 批判性地评估这种非标准的随机化方法的风险效益比.
主要方法:
- 对瘤学临床试验设计现有文献和常见实践的审查.
- 分析二对一随机化对风险效益评估的影响.
主要成果:
- 识别了使用二对一随机化的常见原因.
- 质疑这种设计本质上提供了有利的风险/收益平衡的假设.
结论:
- 在瘤学中,二对一随机化的感知优势可能并不总是超过潜在的缺点.
- 对于使用不平等随机化方案的试验,需要对风险效益比进行进一步的审查.
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