药品临床综合评价中真实世界数据质量控制的探讨和工作经验分享  

Discussion and Work Experience Sharing of Real-World Data Quality Control in the Clinical Comprehensive Evaluation of Drugs

作　　者：尹文俊[1] 谢悦良[1] 黄玉洁 朴慧玲 左笑丛[1] YIN Wenjun;XIE Yueliang;HUANG Yujie;PIAO Huiling;ZUO Xiaocong(The Third Xiangya Hospital of Central South University,Changsha 410013,China)

机构地区：[1]中南大学湘雅三医院,长沙410013

出　　处：《中国药学杂志》2024年第4期369-374,共6页Chinese Pharmaceutical Journal

基　　金：湖南省医学会科研基金-临床药学项目资助(HMA202001003);药源性器官损伤智能防控湖南省工程研究中心;湖南省药学会科研基金资助(2020YXH010);基于真实世界数据的区域内药品临床综合评价质控体系构建研究(国家卫生健康委卫生发展研究中心)。

摘　　要：目的探索药品临床综合评价中真实世界数据的质量控制,推动真实世界数据在药品临床综合评价中科学合理地应用。方法查阅国内外药品临床综合评价真实世界研究数据质量控制的文献,并结合笔者所在省份的药品临床综合评价中心开展的工作经验,探讨药品临床综合评价真实世界研究数据质量控制的内容和流程。结果与结论真实世界研究数据质量控制一般分为内部质控和外部质控,评价方法包括定性评价,定量评价和综合评价,实施阶段可分为项目启动阶段和数据治理后阶段,并在这两阶段各开展一次数据质量控制。本研究归纳总结了药品临床综合评价真实世界研究数据质量控制的内容和流程,为研究者和决策者正确生产和使用基于真实世界数据药品临床综合评价证据提供参考。OBJECTIVE To explore the quality control of real-world data in the drug clinical comprehensive evaluation,and promote the scientific and rational application of real-world data in the drug comprehensive clinical evaluation.METHODS Literature on the quality control of real-world research data in drug clinical comprehensive evaluation was reviewed,and the work experience of the drug clinical comprehensive evaluation center in the province where the author is located was integrated to explore the content and process of quality control of real-world research data in drug clinical comprehensive evaluation.RESULTS AND CONCLUSION Quality control of real-world research data generally includes internal and external controls.Evaluation methods comprise qualitative assessment,quantitative assessment,and comprehensive assessment.The implementation phase can be divided into the project initiation phase and the data governance phase,with a round of data quality control conducted in each phase.This study summarizes the content and process of quality control for real-world research data in the drug clinical comprehensive evaluation,providing a reference for researchers and decision-makers to correctly produce and use evidence from real-world data for drug clinical comprehensive evaluation.

关 键 词：药品临床综合评价 真实世界数据 质量控制 

分 类 号：R951[医药卫生—药学]