Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) and their series interpretation (1): an overview

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Author: WU Yunxiao ^1, ² YAN Jinan ^1, ² NIE Xiaolu ³ ZHAO Houyu ^4, ⁶  ZHAN Siyan ^1, ^2, ^5, ⁶  SUN Feng ^1, ^2, ^5, ⁷

Affiliation: 1. Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China 2. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China 3. Center for Clinical Epidemiology & Evidence-based Medicine, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Beijing 100045, China 4. School of Medicine, Chongqing University, Chongqing 400016, China 5. Center of Postmarketing Safety Evaluation PUHSC, Beijing 100191, China 6. Clinical Epidemiology Research Center, Peking University Third Hospital, Beijing 100191, China 7. School of Traditional Chinese Medicine, Xinjiang Medical University, Urumqi 830017, China

Keywords: Pharmacoepidemiology Methodology Guidelines Interpretation Overview

DOI: 10.12173/j.issn.1004-5511.202412131

Reference: WU Yunxiao, YAN Jinan, NIE Xiaolu, ZHAO Houyu, ZHAN Siyan, SUN Feng. Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) and their series interpretation (1): an overview[J]. Yaowu Liuxingbingxue Zazhi, 2025, 34(1): 2-11. DOI: 10.12173/j.issn.1004-5511.202412131.[Article in Chinese]  Copied

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Abstract

Pharmacoepidemiology is an interdisciplinary discipline that applies epidemiological research methods to evaluate the application and effect of drugs within population. Standardizing pharmacoepidemiological research methods is crucial for ensuring the quality of research and promoting the development of the discipline. The Pharmacoepidemiology Professional Committee of Chinese Pharmaceutical Association developed the Guide on Methodological Standards in Pharmacoepidemiology (1st edition), in 2019, but has not been updated in over five years. Other, countries/regions such as Europe, America, Japan and South Korea have made a lot of progress in developing and updating the guidelines. Therefore, the rapid development of pharmacoepidemiology in our country and the growing need to align with international standards make it essential to update the guidelines. The second edition of the guidelines was developed through a process that included systematic reviews, practical surveys, and multidisciplinary collaboration. Compared with the first edition, the updated version has made many important changes in research design, data sources, specific application scenarios and more, and added new contents such as the application of artificial intelligence. The purpose of this paper is to emphasize the necessity of updating the guidelines, selecting important changes and formulating interpretation plans. It aims to provide references for relevant professionals to comprehensively understand and apply the new guidelines, and to promote the standardized development and quality of pharmacoepidemiologic research in our country, further advancing the field.

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