摘要
目前,单臂试验设置外部对照的方法学研究仍处于发展阶段,面临数据存在样本异质性、偏倚识别及其校正方法不完善等挑战。本文系统检索设置外部对照的单臂试验偏倚控制相关文献,并提取有关信息,总结了研究过程中控制偏倚的策略措施,为相关研究者在单臂试验设置外部对照及控制偏倚方面提供方法学参考。
Methodological studies on external control for single-arm trials are still evolving,facing challenges such as sample heterogeneity and imperfect methods for bias identification and correction.This paper systematically reviews literature related to bias control in single-arm trials with external controls,and summarizes strategies for controlling bias in the research process.It aims to provide methodological guidance for researchers in establishing external controls and minimizing bias in single-arm trials.
作者
秦诗如
汪春楠
赵厚宇
章萌
李戈
孙凤
QIN Shi-ru;WANG Chun-nan;ZHAO Hou-yu;ZHANG Meng;LI Ge;SUN Feng(School of Chinese Materia Medica,Tianjin University of Traditional Chinese Medicine;Department of Epidemiology and Biostatistics,School of Public Health,Peking University;Key Laboratory of Epidemiology of Major Diseases(Peking University);School of Public Health,Tianjin University of Traditional Chinese Medicine;Xinjiang Medical University)
出处
《中国食品药品监管》
2024年第5期42-50,共9页
China Food & Drug Administration Magazine
基金
中国药品监管科学行动计划第三批重点项目(RS2024Z008)。
关键词
外部对照
单臂试验
偏倚风险
偏倚控制
方法学研究
external control
single-arm trial
bias risk
bias control
methodological studies