导入期的设置及其在临床研究中的应用探讨  

Setting of the run-in period and its application in clinical trials

作　　者：韩芳 刘宝利[1] 曹克刚[2,3] 高颖[2,3] HAN Fang;LIU Bao-li;CAO Ke-gang;GAO Ying(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Institute for Brain Disorders Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China;Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京中医药大学中医脑病研究院,北京100700 [3]北京中医药大学东直门医院,北京100700

出　　处：《中国新药杂志》2023年第14期1406-1410,共5页Chinese Journal of New Drugs

基　　金：北京市属医院科研培育计划课题(PZ2020013);国家中医药管理局青年岐黄学者支持项目(国中医药人教函[2022]256号)。

摘　　要：导入期是受试者入组后与随机分组前的一个特定阶段,是很多具有里程碑意义的药物临床试验的重要设计元素,在药物研发中具有重要作用。然而,目前普遍存在导入期在研究方案中设计不规范、研究结果中报告不充分的问题。本文梳理了导入期的定义、类型、周期长短、意义及优缺点,并列举了临床应用案例,以期为临床研究方案中关于导入期的设计及应用提供借鉴。The run-in period is a specific stage after enrollment and before randomization.It is an important design element of many landmark drug clinical trials and plays an important role in drug development.However,the status quo includes non-standard design of run-in period in research protocols and inadequate reporting of run-in period in results.The author summarize the definition,type,duration,significance,advantages and disadvantages of the run-in period,and list clinical application cases,in order to provide reference for the clinical trial design and the application of the run-in period.

关 键 词：导入期 随机对照研究 临床研究设计 

分 类 号：R95[医药卫生—药学]