《药物流行病学研究方法学指南》团体标准的制定过程

Developing Process of ‘Guide on Methodological Standards in Pharmacoepidemiology’

药物流行病学是指采用流行病学的研究方法研究药物及医疗产品在人群中的使用情况和效果,从而评价其安全性和有效性的一门学科。规范化的开展药物流行病学研究是上述工作的基础,因此,中国药学会药物流行病学专业委员会在系统综述国内外药物流行病学研究方法学标准和指南的基础上,结合我国的医疗卫生实践,咨询多学科专家意见,制定出符合我国国情的药物流行病学研究方法学指南,并在其基础上提出了团体标准,为政府监管部门、研究机构、药物生产企业等开展药物流行病学研究提供指引和参考。

Pharmacoepidemiology refers to the use of epidemiological research methods to study the application and use of drugs in large populations to evaluate the safety and efficacy of medical products. Therefore, how to standardize pharmacoepidemiology research is the basis of the above work. Based on a systematic review of national and international pharmacoepidemiological methodological standards and guidelines, and in combination with China's medical and health practice and experts ’ opinions, the Professional Committee of Pharmacoepidemiology of Chinese Pharmaceutical Association has developed guidance and group standard for pharmacoepidemiology research methods. The guideline was designed to provide advice and reference for pharmacoepidemiology research by goveniment, regulatory agencies, research institutions, and pharmaceutical manufacturers in China.