药品安全风险预警大数据决策模型设计和方法学研究

Research on Design and Methodology of Big Data Decision-making Model for Drug Risk Warning

目的:《中华人民共和国国民经济和社会发展第十四个五年规划和2035年远景目标纲要》提出“加快建设数字经济、数字社会、数字政府”。研究药品安全风险预警大数据决策体系,具有提升监管的预见性、靶向性、时效性,是实现药品全生命周期风险管理的支撑条件。方法:采用霍尔三维空间结构系统工程方法分析药品安全风险预警大数据决策体系的数据框架,采用层次分析法(AHP)分析药品安全风险预警大数据决策体系的模型设计准则。结果:基于药品监管系统内外大数据应用现状、八个维度药品监管数据的风险特征和大数据决策模式分析等,AHP评价结果显示“研判发现药品安全系统性风险”“及时消除区域性重大药品安全事件”“构建药品监管质量管理规范(GRP)”三者权重分别为23.21%、22.72%和54.07%,GRP是最为关注方案。结论:模型设计准则对药品安全风险预警大数据决策体系具有理论指导意义。药品安全风险预警大数据决策体系建设的路径,包括应用价值、溯源生成、数据共建共享和推进监管方式转变等方面。

Objective:Outline of the 14th Five-Year Plan for National Economic and Social Development and Vision 2035 of the People’s Republic of China advocates to accelerate the construction of the digital economy,digital society,and digital government.Research on the big data decision-making system for drug risk warning can improve the predictability,targeting,and timeliness of supervision,which is a supporting condition for realizing the life cycle risk management of drugs.Methods:System engineering method of Three-Dimensional Structure of A.D.Hall and Analytic Hierarchy Process(AHP)method are used to analyze the data frame and model design guideline of big data decision-making system for drug risk warning,respectively.Results:Based on the status quo of big data application inside and outside drug regulatory system,the risk feature of drug regulatory data from eight dimensions,and the analysis of big data decision-making models,etc.,the result,evaluated by Analytic Hierarchy Process(AHP)method,shows that the weights of"research and judgment of drug systemic risk","timely elimination of regional major drug safety incidents",and"the construction of Good Regulatory Practice(GRP)"are 23.21%,22.72%and 54.07%,respectively,and GRP is the most concerned solution.Conclusions:The model design criteria have a theoretical instructive significance for the big data decision-making system of drug risk warning,whose building path includes the application value,traceability generation,data co-construction&sharing,the promotion of transformation on the supervision method,and so on.