Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)and their series interpretation(7):selection of control groups
10.12173/j.issn.1005-0698.202506028
- VernacularTitle:《中国药物流行病学研究方法学指南(第2版)》及其系列解读(7):选择对照的方法
- Author:
Qinxi TIAN
1
;
Siyan ZHAN
;
Feng SUN
;
Zhirong YANG
Author Information
1. 南方科技大学生物医学工程系(广东 深圳 518055);深圳理工大学计算机科学与控制工程学院计算生物与医疗大数据系(广东 深圳 518107)
- Publication Type:Journal Article
- Keywords:
Pharmacoepidemiology;
Methodology;
Guidelines;
Control;
Interventional research;
Non-interventional research
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(7):725-733
- CountryChina
- Language:Chinese
-
Abstract:
The selection of an appropriate control group is a critical component of pharmacoepidemiologic research.This article provides an interpretation of the control selection methods outlined in the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition).According to the 2nd edition,studies are categorized into interventional and non-interventional research.In interventional research,control group options include placebo controls,no-treatment controls,active controls,and dose-response controls.For non-interventional research,the gold standard design is the active comparator new user(ACNU)design.When the ACNU design is not feasible,alternative control group strategies should be selected based on the research objective,data sources,exposure characteristics,and potential confounding.These alternatives may include non-user comparators,prevalent user comparators,self-controlled comparators,and external controls.Finally,this article compares the applicability,strengths,and limitations of various control group types.It aims to provide methodological guidance for the scientific selection of control groups in pharmacoepidemiologic studies and to support the conduct of high-quality research.
