摘要
目的为更好地利用符合伦理要求的真实世界数据(real-world data,RWD)开展上市后药品安全性监测和评价。方法从患者安全和数据安全的维度出发,探讨RWD在研究方案中的伦理要求、研究注册和发表的伦理要求、以及数据归属和数据使用权限的伦理考虑。结果与结论建议对真实世界研究(real-world study,RWS)中伦理问题立法并制定政策,同时加强对RWD伦理审查形式创新等相关问题的研究。
Objective To provide a reference for making better use of real-world data(RWD)ethical requirements to carry out post-marketing drug safety monitoring and evaluation.Methods From the perspective of patient safety and data security,discuss the ethical requirements of RWD in the research protocol,the ethical requirements of research registration and publication,and the ethical considerations of data ownership and data usage permissions.Results and Conclusion It is recommended to legislate and formulate policies on ethical issues in real-world study(RWS),and at the same time strengthen research on related issues such as the innovation of RWD ethical review forms.
作者
刘玉强
乔瑞
卓琳
孟若谷
孙凤
詹思延
LIU Yuqiang;QIAO Rui;ZHUO Lin;MENG Ruogu;SUN Feng;ZHAN Siyan(Clinical Epidemiology Research Center,Peking University Third Hospital,Beijing 100191,China;Department of Pharmacy,Changzhi People's Hospital,Changzhi Shanxi 046000,China;School of Public Health Baotou Medical College,Baotou 014040,China;National Institute of Health Data Science,Peking University,Beijing 100191,China;School of Public Health,Peking University,Beijing 100191,China)
出处
《中国药物警戒》
2021年第7期628-631,共4页
Chinese Journal of Pharmacovigilance
基金
国家自然科学基金资助项目(72074011、82003536)
国家药品监督管理局中国药品监管科学行动计划重点项目:(CDRZ20193027)。
关键词
上市后药品监测
数据利用
伦理要求
伦理治理
真实世界数据
真实世界研究
post-marketing drug monitoring
data utilization
ethical requirement
ethical governance
realworld data
real-world study
