早期临床试验扩展至统计分析计划内容指南。
Early phase clinical trials extension to guidelines for the content of statistical analysis plans.
机构信息
Cancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Clinical Trials and Statistics Unit, Institute for Cancer Research, London, UK.
出版信息
BMJ. 2022 Feb 7;376:e068177. doi: 10.1136/bmj-2021-068177.
Abstract
This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders.
摘要
本文报告了早期临床试验统计分析计划内容的指南，通过对各利益相关者进行审查后，对现有指南进行扩展（新增 11 项）和修改（25 项），确保了最低报告分析要求的具体规定。
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