世界科学技术-中医药现代化2025，Vol.27Issue(6)：1509-1513,5.DOI:10.11842/wst.20240829001
中医药领域研究者发起的临床研究科学性审查中常见的方法学问题及解决策略
Methodological Problems and Solutions Commonly Encountered in Scientific Reviews of Investor Initiated Trial in the Field of Traditional Chinese Medicine
摘要
Abstract
The number of investor initiated trial(IIT)in the field of traditional Chinese medicine(TCM)in China has been increasing year by year,but there are still many problems about their scientific validity.Scientific review is the top priority of IIT management,which is of great significance to improve the quality of IIT.Considering the characteristics of IIT in the field of TCM,randomized controlled trials and discuss common methodological problems in the scientific review process of IIT are focused on,such as non-standard placebo setting,unclear research hypothesis or improper selection of hypothesis test type,inappropriate sample size estimation methods,insufficient characteristics of TCM in outcome measures,unreasonable statistical analysis methods,etc.At the same time,corresponding solutions are proposed to increase the scientific and credibility of IIT,thus improving the research quality of IIT in TCM.关键词
中医药/研究者发起的临床研究/科学性审查/方法学Key words
TCM/Investor initiated trial/Scientific review/Methodology分类
医药卫生引用本文复制引用
韩芳,徐佳,刘宝利,刘清泉,李彬,胡晶..中医药领域研究者发起的临床研究科学性审查中常见的方法学问题及解决策略[J].世界科学技术-中医药现代化,2025,27(6):1509-1513,5.基金项目
国家自然科学基金委员会面上项目(82474678):"借用-均衡-降权"历史数据增补中医药RCT对照组样本的设计方法研究,负责人:胡晶 （82474678）
国家自然科学基金委员会面上项目(81973694):基于中医真实疗效病证结合多个主要终点协同评价方法的构建,负责人:胡晶. （81973694）
