摘要
患者参与的重要性在药物研发全生命周期中得到越来越多体现,基于我国推动患者参与药物研发的法律法规体系亟待完善,以及患者缺乏参与药物研发意识、主动性差的现状,本文通过系统梳理近年来欧盟有关促进患者参与药物研发全生命周期的文献和政策文件,归纳了欧洲药品管理局和欧洲患者治疗创新协会在这方面的实践。在此基础上,建议我国从完善政策法规、制定患者参与实践路线图及建立患者多层次教育体系这三方面促进患者参与并推动药物临床价值的实现。
The importance of patient involvement is increasingly reflected in whole lifecycle of medicine R&D process.Due to the situation of China’s immature legal and regulatory system to promote patient involvement in medicine R&D and the lack of patients’awareness and initiative of involvement,this article systematically reviews the latest relevant literatures and policy documents on the promotion of patient involvement in lifecycle of medicine R&D in European Union in recent years,and summarizes the practice of improving patient involvement taken by the European Medicine Agency and the European Patients’Academy on Therapeutical Innovation.On this basis,China is suggested to promote patient involvement and realize the clinical value of drugs from the aspects of improving policies and regulations,formulating practice roadmap of patient participation and establishing multi-level patient education system.
作者
蒋玉霞
茅宁莹
JIANG Yu-xia;MAO Ning-ying(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第19期2312-2318,共7页
Chinese Journal of New Drugs
基金
国家社科基金重大项目(15ZDB167)
中国药科大学“双一流”学科创新团队建设项目(CPU2018GY39)
关键词
患者参与
药物研发
欧盟
patient involvement
medicine R&D
European Union
