Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (6): 703-708.
DOI: 10.19803/j.1672-8629.20240016

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Evaluation of drug safety with multicenter real-world data

WANG Chunnan1, QIN Shiru1△, ZHANG Meng2,3, SONG Haibo4, LIU Junchang5,6, LI Ge7#, SUN Feng2,3,5,*   

  1. 1School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;
    2Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;
    3Key Laboratory of Epidemiology of Major Diseases (Peking University), Beijing 100191, China;
    4Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
    5Xinjiang Medical University, Xinjiang 830017, China;
    6Xinjiang Uygur Autonomous Region Academy of Traditional Chinese Medicine, Urumqi Xinjiang 830000, China;
    7School of Public Health of TJUTCM, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
  • Received:2024-01-11 Online:2024-06-15 Published:2024-06-18

Abstract: Objective To explore the progress, hot spots, and developments of research on drug safety evaluation based on multicenter real-world data. Methods PubMed, Web of Science, and Scopus were searched for literature on drug safety evaluation using multicenter real-world data. Firstly, bibliometrix was used for visual analysis of the time the included literature was published and the distribution of countries and journals. In addition, the frequency, co-occurrence, and diachronic changes of keywords were displayed. Information on the target diseases, intervention drugs, research safety outcomes, real-world data sources, multicenter data sharing was retrieved. Results A total of 405 publications in 2004-2023 were included in the analysis, and the number of publications increased year by year. Research focused on pharmacological interventions in neoplasms treatment, including targeted drugs, chemotherapeutic drugs, glucocorticoids, immunological agents, oral anticoagulants and antiplatelet drugs for circulatory disorders. The keyword co-occurrence analysis found 10 keyword clusters, the top two of which involved safety and atrial fibrillation. The most important source of data was the registry (217/405, 53.5%) in these studies. Currently, most research centers shared data within the country, so research data mostly came from more than 10 institutions (158/280, 56.4%). Data was shared across countries in Europe in this field. Conclusion There is increasing research on drug safety evaluation based on multicenter real-world data. The related research covers a wide range, such as neoplasms and circulatory system diseases. Multicenter data sharing between countries is increasing. Advances in information technology can facilitate inter-country RWD information exchange. The more commonly used real-world data is registry data and hospital database information. Building a global and multicenter data management platform and sharing real-world multi-source data will catch on.

Key words: drug safety, pharmacovigilance, real-world data, bibliometrics, Bibliometrix, multicenter

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