欧盟《药物流行病学研究方法学标准指导手册》译介

在药品上市后开展药物警戒活动成为世界各国药品监管机构最重要的工作之一。当前,药物警戒在中国日益受到政府、医药界和公众的重视。为了支持高质量的药物流行病学研究,并激励有益于患者和公众医疗健康的创新,欧盟药品管理局组织欧盟药物流行病学和药物警戒网络中心制定了《药物流行病学研究方法学标准指导手册》,作为欧盟药物警戒工作方法学的标准参考文件。该指导手册重点是从科学的角度提供方法学指导,对开展药物流行病学的法律背景和伦理要求、研究方案的一般考虑、研究问题的确立、数据采集方法、研究设计方法、统计和流行病学分析计划、质量控制和质量保证、不良事件的报告、信息交流等相关内容提出了方法学方面的具体指导性建议。该文拟对该指导手册的主要内容进行介绍,以期为我国的药物警戒工作提供相关的技术和方法学参考。

Translation and introduction of Guide to Methodological Standards in Pharmacoepidemiology

Post-marketing pharmacovigilance of drugs has become one of the most important activities for regulatory authorities. In China, pharmacovigilance is currently receiving the attention of government, pharmaceutical industries and the public. In order to support high quality pharmacoepidemiological studies and to stimulate innovation that benefits patients and the wider public, the European medicines agency (EMA) organized the European network of centres for pharmacoepidemiology and pharmacovigilance (ENCePP) to formulate and publish the Guide on Methodological Standards in Pharmacoepidemiology as a reference document for the methodological standards of pharmacovigilance activities in the European union (EU). It supplies methodological and scientific guidance, and advises on technical aspects of conducting parmacoepidemiological studies and undertaking parmacovigilance. As advice includes: legal and ethical requirements, general aspects of study protocols, research questions, approaches to data collection, study designs and methods, statistical and epidemiological analysis plans, quality control and quality assurance, reporting of adverse events to regulatory authorities, communication of findings, and so on. The translation and introduction of this guidance can provide a useful technical and methodological reference for us to carry out the pharmacovigilance (especially for parenterally administered Chinese medicine safety monitoring).