摘要
非劣效性设计临床试验是一类检验试验组治疗手段是否不劣于对照组治疗手段的随机对照临床试验。本文简要介绍非劣效性设计临床试验的基本概念、设计要点及其与等效性和优效性设计临床试验的差异,并通过具体案例解读,帮助读者全面了解、实施和评价非劣效性设计方法。
A noninferiority design clinical trial is a type of randomized controlled clinical trials that examines whether the treatment of the experimental group is not inferior to the treatment of the control group.This paper introduces the basic concept,design points,comparison with equivalence and superiority trials,and case analysis to help readers fully understand,implement and evaluate noninferiority design clinical trials.
作者
周齐
严鸿伊
张艳丽
潘岳松
ZHOU Qi;YAN Hongyi;ZHANG Yanli;PAN Yuesong(Beijing Tiantan Hospital,Capital Medical University,National Clinical Research Center for Neurological Diseases,Beijing 100070,China)
出处
《中国卒中杂志》
2023年第6期636-644,共9页
Chinese Journal of Stroke
基金
国家重点研发计划(2022YFC3602500)。
关键词
临床研究
随机对照试验
非劣效
界值
Clinical trial
Randomized controlled trial
Noninferiority
Margin
