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Home Articles Vol 34,2025 No.7 Detail

Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) and their series interpretation (7): selection of control groups

Published on Jul. 28, 2025Total Views: 41 times Total Downloads: 9 times Download Mobile

Author: TIAN Qinxi 1, 2 ZHAN Siyan 3, 4, 5, 6 SUN Feng 3, 4, 6, 7, 8, 9 YANG Zhirong 2, 10

Affiliation: 1. Department of Biomedical Engineering, Southern University of Science and Technology, Shenzhen 518055, Guangdong Province, China 2. Department of Computational Biology and Medical Big Data, Faculty of Computer Science and Engineering, Shenzhen University of Advanced Technology, Shenzhen 518107, Guangdong Province, China. 3. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China 4. Key Laboratory of Epidemiology of Major Diseases (Peking University, Ministry of Education), Being 100191, China 5. Clinical Epidemiology Research Center, Peking University Third Hospital, Beijing 100191, China 6. Center for Post-Marketing Safety Evaluation of Drugs, Peking University Health Science Center, Beijing 100191, China 7. Department of Ophthalmology, Peking University Third Hospital, Beijing 100191, China 8. College of Traditional Chinese Medicine, Xinjiang Medical University, Urumgi 830017, China 9. School of Medicine, Shihezi University, Shihezi 832000, Xinjiang Uygur Autonomous Region, China 10. Center for AI in Medicine, Artificial Intelligence Research Institute, Shenzhen University of Advanced Technology, Shenzhen 518107, Guangdong Province, China

Keywords: Pharmacoepidemiology Methodology Guidelines Control Interventional research Non-interventional research

DOI: 10.12173/j.issn.1005-0698.202506028

Reference: TIAN Qinxi, ZHAN Siyan, SUN Feng, YANG Zhirong. Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) and their series interpretation (7): selection of control groups[J]. Yaowu Liuxingbingxue Zazhi, 2025, 34(7): 725-733. DOI: 10.12173/j.issn.1005-0698.202506028.[Article in Chinese]

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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.

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References

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