相关实验视频
Updated: Feb 10, 2026

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In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
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在包括安慰剂在内的三臂等价性试验中,对二元临床终点进行样本大小计算,其中包括安慰剂
Fei Yu1, Shuming Ji2,3, Zaiyun Xiao1
1Department of Organization and Personnel, Sichuan Clinical Research for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, China.
iScience
|February 9, 2026
概括
监管机构建议对药物等价性进行三臂试验. 这项研究引入了新的样本大小计算,考虑了所有所需的测试,确保了强大的仿制药药物评估.
科学领域:
- 临床试验 临床试验
- 药物经济学 药物经济学
- 生物统计学 生物统计学
背景情况:
- 监管机构建议进行三臂等效试验,将仿制药 (T) 与创新药 (R) 与安慰剂 (P) 进行比较.
- 只有在满足T与R的等价性测试和T与P和R与P的优越性测试的情况下,才会确认等价性.
研究的目的:
- 为使用二进制终点的三臂等价性试验提出新的样本大小计算方法.
- 解决现有方法的局限性,这些方法忽视了R与P优越性测试.
主要方法:
- 为三臂试验开发了两种新的样本大小计算方法.
- 纳入了同等性测试 (两个率的比率) 和两个优越性测试 (T与P,R与P).
- 提出了一种网格搜索方法,以优化三支机构的样本大小分配.
主要成果:
- 提出的方法同时考虑所有必要的统计学同等性测试.
- 网格搜索有助于确定治疗组中最有效的参与者分布.
- 确保所有假设测试的足够的统计能力.
结论:
- 新的样本大小计算方法为设计三臂等效试验提供了更全面的方法.
- 这些方法通过考虑所有监管标准来提高确定药物等价性的可靠性.
- 优化的样本分配提高了试验效率和资源利用率.
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