国内外药品上市后安全性研究的方法学要求比较

Comparison on Methodological Guidelines for Drug Post-authorization Safety Study among Different Authorities

事先制定方法学规范是保障研究流程化开展,增强研究结果真实性和可重复性的最重要措施,也是研究方案的核心内容。本文依据各国和不同国际组织的药品上市后安全性研究(PASS)指南性文件,在已发表的系列专题文章所梳理的PASS方法学内容覆盖和详尽程度差异基础上,进一步比较研究范畴与研究目的、设计类型、数据来源、设计要素、统计分析计划和各环节质量控制的方法学技术规范,提出推荐性方法学实践标准,为我国PASS方法学指南制定提供理论依据。

Formulating methodological guidelines before starting the drug post-authorization safety study(PASS),an overriding section composed the study protocol,to great extent warrants the standardized study process and consequently improves the reliability and reproducibility of study results.Based on previous wholesale comparison on methodological indexes of this series,sophisticated details on scope of study,study objectives,study design,data source,key variables,statistical analysis plan and quality management at all stages,etc.will be comprehensively further compared in this paper.Through this,well-instructed methodological recommendations on PASS would be proposed,enlightening authorized guideline of drug PASS methodology in China.