Z X Lu, M S Li, J H Pan, Y W Wu, H L Li, E Yu, H M Wo, S W Tang, Y Zhao, J C Dai, H G Yi
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引用次数: 0
Abstract
To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 (P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.
期刊介绍：
Chinese Journal of Epidemiology, established in 1981, is an advanced academic periodical in epidemiology and related disciplines in China, which, according to the principle of integrating theory with practice, mainly reports the major progress in epidemiological research. The columns of the journal include commentary, expert forum, original article, field investigation, disease surveillance, laboratory research, clinical epidemiology, basic theory or method and review, etc.
The journal is included by more than ten major biomedical databases and index systems worldwide, such as been indexed in Scopus, PubMed/MEDLINE, PubMed Central (PMC), Europe PubMed Central, Embase, Chemical Abstract, Chinese Science and Technology Paper and Citation Database (CSTPCD), Chinese core journal essentials overview, Chinese Science Citation Database (CSCD) core database, Chinese Biological Medical Disc (CBMdisc), and Chinese Medical Citation Index (CMCI), etc. It is one of the core academic journals and carefully selected core journals in preventive and basic medicine in China.
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