Interpretation of the Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) (III): comparison of global guidelines

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Author: YAN Jinan ^1, ² WU Yunxiao ^1, ² NIE Xiaolu ³ ZHAO Houyu ⁴  ZHAN Siyan ^1, ^2, ^4, ⁵  SUN Feng ^1, ^2, ^5, ^6, ^7, ⁸

Affiliation: 1. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China 2. Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, 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. Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China 5. Center of Postmarketing Safety Evaluation PUHSC, Beijing 100191, China 6. Department of Ophthalmology, Peking University Third Hospital, Beijing 100191, China 7. School of Traditional Chinese Medicine, Xinjiang Medical University, Urumqi 830017, China 8. School of Medicine, Shihezi University, Shihezi 832000, Xinjiang Uygur Autonomous Region, China

Keywords: Pharmacoepidemiology Methodological guideline Systematic review

DOI: 10.12173/j.issn.1005-0698.202503119

Reference: YAN Jinan, WU Yunxiao, NIE Xiaolu, ZHAO Houyu, ZHAN Siyan, SUN Feng. Interpretation of the Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) (III): comparison of global guidelines[J]. Yaowu Liuxingbingxue Zazhi, 2025, 34(3): 241-259. DOI: 10.12173/j.issn.1005-0698.202503119.[Article in Chinese]  Copied

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Abstract

It has been not been updated for nearly 5 years since the Pharmacoepidemiology Professional Committee of the Chinese Pharmaceutical Association released the Guide on Methodological Standards in Pharmacoepidemiology in China (1st edition) in 2019, and an update is urgently needed. This study adopts a systematic review approach to comprehensively search for global pharmacoepidemiology methodological guidelines and analyze their development status. By extracting the frameworks and key elements of the guidelines, the China’s guide was compared with other included guidelines, its shortcomings were analysed, and pragmatic and feasible suggestions for improvement in line with China's national conditions, were proposed in order to provide references for updating China's guide. A systematic search was conducted by searching PubMed, Embase, CNKI, WanFang Data and 17 official websites of international academic organizations for pharmacoepidemiology and regulatory agencies from countries or regions including Europe, the United States, Japan, and China, etc., and relevant guidelines or standards were screened based on predefined inclusion and exclusion criteria, resulting in the inclusion of 33 methodological guidelines or standards for pharmacoepidemiological studies. A qualitative synthesis approach was then employed to extract core elements from the guidelines through thematic categorization and content summarization, followed by a descriptive comparative analysis. The results indicate that the 1st edition of the China’s guide provides relatively comprehensive guidance on adverse drug reaction reporting and publication of research findings. However, there are gaps in study protocol development, data analysis during study implementation, study reporting, and specific study scenarios. By integrating and drawing upon the latest international pharmacoepidemiology methodology guidelines while balancing comprehensiveness, practicality, and user-friendliness, this study provides recommendations for updating the China’s guide.

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