设置外对照的单臂试验研究现状及其偏倚风险评估案例分析  

Current Status of Single-arm Trials with External Controls and Case Analysis of Bias Risk Assessment

作　　者：李戈[1] 孙凤[2] LI Ge;SUN Feng(School of Public Health and Health Sciences,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Department of Epidemiology and Health Statistics,School of Public Health,Peking University,Beijing 100191,China)

机构地区：[1]天津中医药大学公共卫生与健康科学学院,天津301617 [2]北京大学公共卫生学院流行病与卫生统计学系,北京100191

出　　处：《中国药物评价》2022年第5期363-369,共7页Chinese Journal of Drug Evaluation

基　　金：中国药品监管科学行动计划第二批重点项目(No.[2021]37-10);海南博鳌乐城国际医疗旅游先行区管理局真实世界研究专项计划项目(HNLC2022RWS012);中国中医药循证医学中心“业务研究室主任专项”(2020YJSZX-2)。

摘　　要：本文首先概述了设置外对照的单臂试验的研究现状。然后重点介绍了采用非随机干预性研究偏倚评估工具(Risk of Bias in Non-randomized Study-of Interventions,ROBINS-I)评估设置了外对照的单臂试验,并举例说明偏倚评估流程和结果,为研究者提高此类研究偏倚的识别与控制提供参考。综上,目前基于真实世界数据设置外对照的单臂试验尚在起步阶段,仍缺乏专用于其偏倚评估的工具,有待进一步研发。This paper outlines the current state of single-arm trials(SAT)with external controls,and then provides an example of the bias assessment process and results with the Risk Of Bias In Non-randomized Study-of Interventions(ROBINS-I)tool to improve the identification and control of bias for investigators.In conclusion,SATs with external controls are still in the development stage and there is a lack of dedicated tools to assess bias.

关 键 词：单臂试验 外对照 偏倚评估 

分 类 号：R195.1[医药卫生—卫生统计学]