随机对照试验设计及实践心得

陶刚; 郑小卫; 张轶雯; 马培煜; 杨秀丽; 石佳娜; 宣自学; 黄萍<sup>*</sup>

引用本文:	陶刚,郑小卫,张轶雯,马培煜,杨秀丽,石佳娜,宣自学,黄萍.随机对照试验设计及实践心得[J].中国现代应用药学,2022,39(24):3280-3283.
	TAO Gang,ZHENG Xiaowei,ZHANG Yiwen,MA Peiyu,YANG Xiuli,SHI Jiana,XUAN Zixue,HUANG Ping.Experience in the Design and Implementation of Randomized Controlled Trials[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(24):3280-3283.

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随机对照试验设计及实践心得
陶刚¹, 郑小卫², 张轶雯², 马培煜³, 杨秀丽², 石佳娜², 宣自学², 黄萍²
1.浙江省医疗健康集团杭州医院肿瘤综合科, 杭州 310022;2.浙江省人民医院药学部, 杭州医学院附属人民医院, 杭州 310014;3.浙江工业大学药学院, 杭州 310014

摘要:

随机对照试验是医学研究最重要的研究类型之一,科学的设计和规范的实施是保证研究结果真实可靠的重要前提。本文结合临床试验方案设计的准则及笔者实践心得,对开展随机对照试验的研究终点、样本量估算、随机化和分配隐藏、盲法、分析集、中期分析、在线注册、数据管理、研究报告撰写等关键环节进行了简明的总结,以期为初次开展临床试验项目的人员提供参考。

关键词: 随机对照试验(RCT) 研究设计实践

DOI：10.13748/j.cnki.issn1007-7693.2022.24.014

分类号:R969.4

基金项目:国家自然科学基金(82003189)；浙江省内分泌腺疾病重点实验室(2021E10020)；浙江省医药卫生科技计划项目(2023KY521)；浙江省卫生高层次人才培养(浙卫办[2022]32号)；浙江省医坛新秀(浙卫办[2020]18号)；浙江省“万人计划”科技创新领军人才项目(2020R52029)

Experience in the Design and Implementation of Randomized Controlled Trials

TAO Gang¹, ZHENG Xiaowei², ZHANG Yiwen², MA Peiyu³, YANG Xiuli², SHI Jiana², XUAN Zixue², HUANG Ping²

1.Department of comprehensive therapy of Oncology, Zhejiang Medical and Health Group Hangzhou Hospital, Hangzhou 310022, China;2.Department of Pharmacy, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou 310014, China;3.College of Pharmacy, Zhejiang University of Technology, Hangzhou 310014, China

Abstract:

Randomized controlled trial is one of the most important types of medical research. Scientific design and standardized implementation are important prerequisites to ensure the authenticity and reliability of research results. The author briefly summarized the key points of RCT, such as research endpoint, sample size estimation, randomization and allocation concealment, blinding, analysis set, interim analysis, registration, data management and research reporting. By sharing practical experience, this paper provided help for beginners of clinical research.

Key words: randomized controlled trials(RCT) study design practice