临床试验与中间分析:标准化术语以提高清晰度
Elina Asikanius1, Benjamin Hofner2,3, Lisa V Hampson4
1Finnish Medicines Agency, Turku, Finland.
Trials
|July 14, 2025
概括
临床试验中的临时分析是常见的,但往往被误解. 本文阐明了关键概念,并规范了术语,以减少研究人员,监管机构和行业专业人士之间的混乱.
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
- 监管科学 监管科学
背景情况:
- 在临床试验中,临时分析经常用于组序列决策.
- 已经确立的方法存在,但实际应用和解释导致利益相关者感到困惑.
研究的目的:
- 为临时分析概念提供多利益相关者的视角.
- 为中间分析引入标准术语.
- 为了减轻误解和改善关于中间分析的讨论.
主要方法:
- 一种合作方法,涉及来自行业,学术界和监管机构的统计学家.
- 专注于关键概念和中间分析的操作化.
- 制定标准化术语的开发.
主要成果:
- 在中期分析的操作化和解释中确定了一些关键的混问题.
- 提出了标准化的术语来解决这些模两可的问题.
- 促进了不同利益相关者群体之间的共同理解.
结论:
- 标准化术语对于在临床试验中间分析中进行清晰沟通至关重要.
- 关于概念和语言的多利益相关者共识改善了试验的进行和决策.
- 这项工作旨在促进更有效,更透明的临床试验流程.
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