健康发展与政策研究2024，Vol.27Issue(5)：432-436,5.DOI:10.12458/HDPR.202408073
药品临床综合评价项目真实世界研究质量控制规范(2024版)
Guidelines for quality control in real-world studies of drug clinical comprehensive evaluation projects (version 2024)
尹璇 1张晶晶 2马爱霞 1周吉芳 1黄睿健 1伍俊妍 3张方 4陈昊 5朱建国 2李俐 6束雅春 7陈楠8
作者信息
- 1. 中国药科大学国际医药商学院,江苏南京 211198
- 2. 苏州大学附属第一医院,江苏苏州 215006
- 3. 中山大学孙逸仙纪念医院,广东广州 510120
- 4. 广州市中维公益卫生技术评估研究所,广东广州 511400
- 5. 华中科技大学,湖北武汉 430074
- 6. 南京大学医学院附属鼓楼医院药学部,江苏南京 210009
- 7. 江苏省海滨康复医院,江苏连云港 222042
- 8. 郑州市人民医院,河南郑州 450000
- 折叠
摘要
Abstract
The clinical comprehensive evaluation of drugs based on real-world data is a vital approach for assessing the clinical value of drugs,including effectiveness,safety,and cost-effectiveness,in real-world healthcare settings.Currently,most real-world studies in China have yet to establish standardized quality control management protocols.The drug clinical comprehensive evaluation team should develop the Quality Control Standards for Real-World Research in Clinical Comprehensive Evaluation of Drugs (hereinafter referred to as the "Standards"),emphasizing scientific rigor,compliance,and reliability.These Standards provide operational guidelines for researchers,ensuring that studies are standardized,homogeneous,and possess a high degree of external validity.They systematically cover key aspects such as research objectives,study design,data sources and preprocessing,statistical analysis,and result interpretation.The Standards serve as a benchmark for quality control management of drug clinical evaluations based on real-world research,aiming to enhance the quality of such research and provide robust scientific support for drug supply security decisions and clinical treatment decision-making.关键词
真实世界研究/质量控制/循证医学/药品临床综合评价Key words
real-world study/quality control/evidence-based medicine/clinical comprehensive evaluation of drugs分类
医药卫生引用本文复制引用
尹璇,张晶晶,马爱霞,周吉芳,黄睿健,伍俊妍,张方,陈昊,朱建国,李俐,束雅春,陈楠..药品临床综合评价项目真实世界研究质量控制规范(2024版)[J].健康发展与政策研究,2024,27(5):432-436,5.
