[1]龚睿婕 茅淑倩 刘景壹 吴强松 周祺 刘敏 林婉靖 李梦 郭翔.预防性疫苗注册临床试验项目分析[J].中国卫生质量管理,2025,32(02):077-82.[doi:10.13912/j.cnki.chqm.2025.32.2.18]
　GONG Ruijie,MAO Shuqian,LIU Jingyi.Analysis of Clinical Trial Items of Preventive Vaccine Registration[J].Chinese Health Quality Management,2025,32(02):077-82.[doi:10.13912/j.cnki.chqm.2025.32.2.18]
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预防性疫苗注册临床试验项目分析()
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《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R]

卷:
第32卷
期数:
2025年02期
页码:
077-82
栏目:
疾病预防控制质量
出版日期:
2025-02-15

文章信息/Info

Title:
Analysis of Clinical Trial Items of Preventive Vaccine Registration
作者:
龚睿婕 茅淑倩 刘景壹 吴强松 周祺 刘敏 林婉靖 李梦 郭翔
徐汇区疾病预防控制中心
Author(s):
GONG Ruijie; MAO Shuqian; LIU Jingyi
Xuhui District Center for Disease Control and Prevention
关键词:
预防性疫苗; 临床试验; 疾病预防控制中心
Keywords:
Preventive Vaccines;  Clinical Trials;  Center for Disease Control and Prevention
分类号:
R186
DOI:
10.13912/j.cnki.chqm.2025.32.2.18
文献标志码:
A
摘要:
目的调查我国注册预防性疫苗临床试验项目开展现状，分析存在问题，为优化我国预防性疫苗临床试验组织和质量管理体系提供参考。方法检索我国 “药物临床试验登记与信息公示平台”和“药物临床试验机构备案管理信息平台”，收集并汇总预防性疫苗临床试验注册信息及备案信息。结果共纳入543个临床试验项目，涉及36个病种。73个（13.44%）项目设立了数据监查委员会，178个（32.78%）项目为受试者购买了试验伤害保险，且占比逐年升高。参与预防性疫苗临床试验项目机构多为疾控机构，占比91.34%。 结论我国预防性疫苗临床试验项目数量明显增加，数据监查意识和受试者安全保障意识显著增强，但疫苗研发热点与国际存在差异，受试者伤害保障相关法律法规尚不完善，参与机构发展不均衡。
Abstract:
ObjectiveTo investigate the current situation of registered preventive vaccine clinical trial projects in China, analyze the existing problems, and provide reference for optimizing the organization and quality management system of preventive vaccine clinical trials in China. MethodsThe "Drug Clinical Trial Registration and Information Publicity Platform" and "Drug Clinical Trial Institution Record Management Information Platform" in China were searched to collect and summarize the registration information and record information of preventive vaccine clinical trials.ResultsA total of 543 clinical trials involving 36 diseases were included. 73(13.44%) projects established data monitoring committee, and 178(32.78%) projects purchased test injury insurance for subjects, and the proportion increased year by year. Most of the institutions participating in the preventive vaccine clinical trial projects were disease control institutions, accounting for 91.34%.Conclusion The number of clinical trial projects of preventive vaccine in China has increased significantly, and the awareness of data monitoring and safety assurance of subjects has increased significantly. However, the hotspots of vaccine research and development are different from those in the world. The laws and regulations related to the protection of subjects ’ injury are not perfect, and the development of participating institutions is not balanced.

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更新日期/Last Update: 2025-02-15