透明的报告适应性临床试验使用同时随机分类队列
Ian C Marschner1, Mark Jones2, James A Totterdell2
1NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
BMJ medicine
|September 22, 2023
概括
适应性临床试验需要新的报告方法,因为设计不断变化. 同时随机的队列报告提供了一种透明和公正的方法来呈现结果,改善了对适应性试验数据的解释.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 医学研究设计 医学研究设计
背景情况:
- 随着时间的推移,自适应性临床试验不断发展,引入潜在的混.
- 标准报告方法与适应性试验设计的复杂性作斗争.
- 治疗臂比较中的偏差可能来自设计变化.
研究的目的:
- 提出适应性临床试验的新型报告框架.
- 作为一种解决方案,同时引入随机分类队列报告.
- 倡导在适应性试验报告中常规使用该框架.
主要方法:
- 开发了一个报告框架,基于同时随机排序的队列报告.
- 定义一个同时随机排序的队列作为一个具有一致治疗可用性和分配概率的子组.
- 建议报告每个队列的随机化前特征和随机化后结果.
主要成果:
- 拟议的框架提供了基线平衡的透明显示.
- 它可以在适应性试验中对随机治疗进行公正的比较.
- 这种方法提高了不断变化的试验设计结果的可解释性.
结论:
- 同时随机的队列报告解决了适应性试验标准方法的缺陷.
- 这种方法确保了透明度,并减少了报告中的偏见.
- 建议定期采用该框架,以改善适应性试验分析.
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