Interpretation of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)(Ⅲ):comparison of global guidelines
10.12173/j.issn.1005-0698.202503119
- VernacularTitle:《中国药物流行病学研究方法学指南(第2版)》系列解读(3):全球指南的对比
- Author:
Jinan YAN
1
;
Yunxiao WU
;
Xiaolu NIE
;
Houyu ZHAO
;
Siyan ZHAN
;
Feng SUN
Author Information
1. 北京大学公共卫生学院流行病与卫生统计学系(北京 100191);重大疾病流行病学教育部重点实验室(北京大学)(北京 100191)
- Publication Type:Journal Article
- Keywords:
Pharmacoepidemiology;
Methodological guideline;
Systematic review
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(3):241-259
- CountryChina
- Language:Chinese
-
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.
