Suitability assessment of real-world data in active post-marketing surveillance of vaccine safety

doi:10.19803/j.1672-8629.20230308

Abstract

Abstract: Objective To sort out the suitability assessment content and methods of real-world data(RWD) in active post-marketing surveillance of vaccine safety, and preliminarily build a suitability assessment framework that meets the characteristics of RWD in China. Methods The scoping review was used to retrieve and screen studies and guideline documents related to the suitability assessment of RWD in active post-marketing surveillance of vaccine safety, extract and map suitability assessment indicators and content, and combine the framework synthesis to preliminarily determine the hierarchical suitability assessment structure. Results 51 articles were included, including 8(15.7%) in China. 229 assessment indicators were extracted to form a framework for suitability assessment of RWD in active post-marketing surveillance of vaccine safety, including 3 primary indicators(data traceability, data reliability, and data relevance), 8 second-level indicators (basic characteristics of data sources, data collection, data governance, completeness, accuracy, data content, data coverage, and data characteristics), and 31 third-level indicators. Accuracy of key variables(60.8%), population coverage(45.1%), timeliness(39.2%), and completeness of key variables(35.3%) were the third-level indicators with the highest frequency in the included articles. The distribution of the third-level indicators varied according to the type of RWD, vaccine, and health system. Conclusion There is still a lack of standardized RWD suitability assessment dimensions and methods in the active surveillance of vaccine safety. The suitability assessment framework summarized in this study provides a reference for relevant studies, but expert validation is still needed in the future to ensure the scientific nature of the indicator system and thus promotes the construction of the active surveillance system of vaccine safety in China.

Key words: real-world data, vaccine, post-marketing, active surveillance, data, suitability, evaluations

CLC Number:

R954
R994.11

WU Yunxiao, YU Yuelin, WANG Shengfeng, SUN Feng, MENG Ruogu, ZHAN Siyan. Suitability assessment of real-world data in active post-marketing surveillance of vaccine safety[J]. Chinese Journal of Pharmacovigilance, 2023, 20(10): 1081-1089.

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