一个历史性的注意事项:重新发现Korn and Freidlin (2011) 尚未发表的回应
Hongjian Zhu1, William F Rosenberger2, Feifang Hu3
1SVP, Global Head of Statistics and Data Science, SystImmune, Inc., Abb Vie Inc, 4730 Deepwater Ln, SUGARLAND, TX, USA.
Statistical methods in medical research
|January 28, 2026
概括
临床试验中的响应适应性随机化 (RAR) 仍在争论中. 这篇文章回顾了最初的论点,并从历史角度讨论了RAR方法的发展.
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
- 医学研究伦理学医学研究伦理学
背景情况:
- 在临床试验中,响应适应性随机化 (RAR) 的使用一直是持续争议的主题.
- 科恩和弗雷德林2011年的一篇文章加剧了辩论,导致了几个回应.
- 由朱,罗森伯格和胡的重要回应,以前未发表,是特色.
研究的目的:
- 介绍朱,罗森伯格和胡的未发表的回应,直接看看他们的论点.
- 通过检查最初的论点和随后的发展,提供对响应适应性随机化辩论的历史视角.
- 在当代临床试验设计考虑中将历史性辩论置于背景下.
主要方法:
- 重温并呈现来自朱,罗森伯格和胡未发表的回应的原始论点.
- 分析自2011年辩论以来响应适应性随机化 (RAR) 方法的演变.
- 包含关于当前RAR实施挑战和细微差别的结论性评论.
主要成果:
- 这篇文章有助于重新审视有关响应适应性随机化 (RAR) 的基本论点.
- 它强调了随着时间的推移,RAR统计方法的进展和多样化.
- 纳入当代见解为历史辩论和当前实践提供了一座桥梁.
结论:
- 朱,罗森伯格和胡的回应的再出版为响应适应性随机化辩论提供了关键的历史背景.
- 了解RAR方法的演变对于其道德和有效实施至关重要.
- 当代临床试验设计必须仔细考虑响应适应性随机化的复杂性和细微差别.
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