中国食品药品监管Issue(5):42-50,9.DOI:10.3969/j.issn.1673-5390.2024.05.005
设置外部对照的单臂试验偏倚控制方法研究进展分析
Analysis of Research Progress on Bias Control Methods for Single-Arm Trials with External Controls
摘要
Abstract
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.关键词
外部对照/单臂试验/偏倚风险/偏倚控制/方法学研究Key words
external control/single-arm trial/bias risk/bias control/methodological studies分类
医药卫生引用本文复制引用
秦诗如,汪春楠,赵厚宇,章萌,李戈,孙凤..设置外部对照的单臂试验偏倚控制方法研究进展分析[J].中国食品药品监管,2024,(5):42-50,9.基金项目
中国药品监管科学行动计划第三批重点项目(RS2024Z008) (RS2024Z008)