基于因子分析的疫苗临床试验质量管理研究

Study on quality management of vaccine clinical trials based on factor analysis

目的为提高疫苗临床试验质量管理的效率,初步构建疫苗临床试验现场质量管理模型。方法采用文献法收集疫苗临床试验质量管理影响因子,编制成包括个人基本信息及影响质量管理的因子共105个条目的问卷,对柳州市和下辖6个县疾病预防控制中心的203名疫苗临床试验研究者进行问卷调查,应用主成分和因子分析法对数据进行分析。结果建立了包含试验方案遵循、受试者管理、疫苗管理、硬件设施、机构资质5个维度28个条目疫苗临床试验质量管理模型。结论构建的疫苗临床试验现场质量管理模型,为疫苗临床试验现场质量管理工作的推广以及提高其管理效率提供理论依据。

Objective To preliminarily construct vaccine clinical trials on-site quality management model,so as to improve the efficiency of vaccine clinical trial quality management.Methods The influencing factors of vaccine clinical trial quality management were collected by literature method,and a questionnaire with 105 items including basic personal information and factors influencing quality management was prepared.The questionnaire survey was conducted among 203 vaccine clinical trial researchers from Centers for Disease Control and Prevention in Liuzhou city and 6 counties subject to its jurisdiction.The collected data was analyzed by principal component analysis and factor analysis.Results A vaccine clinical trial quality management model with 28 items was established,which included five dimensions: protocol compliance,subject management,vaccine management,hardware facilities,and institutional qualification.Conclusion This vaccine clinical trials on-site quality management model provides a theoretical basis for the promotion of quality management of vaccine clinical trial and the improvement of its management efficiency.