Objective To analyze the research and application status of real-world evidence(RWE)in the European Union(EU)and provide a reference for China’s government.Methods By consulting the policy guidelines issued by EU EMA...Objective To analyze the research and application status of real-world evidence(RWE)in the European Union(EU)and provide a reference for China’s government.Methods By consulting the policy guidelines issued by EU EMA and the documents of European countries at home and abroad,the basic principles and case notes of EU RWE implementation were comprehensively analyzed.Results and Conclusion Research on RWE in EU is mainly carried out from four aspects:R&D decision,application of expanded trial certificate,medical insurance decision,and supervision decision,which plays an important role in the progress of European clinical medicine.Therefore,researchers in China should draw lessons from these four perspectives and design reasonable research directions and programs.展开更多
基金Special Fund of the National Medical Products Administration’s Drug Regulatory Science Research Base-Research Institute of Drug Regulatory Science of Shenyang Pharmaceutical University(No.2020jgkx005).
文摘Objective To analyze the research and application status of real-world evidence(RWE)in the European Union(EU)and provide a reference for China’s government.Methods By consulting the policy guidelines issued by EU EMA and the documents of European countries at home and abroad,the basic principles and case notes of EU RWE implementation were comprehensively analyzed.Results and Conclusion Research on RWE in EU is mainly carried out from four aspects:R&D decision,application of expanded trial certificate,medical insurance decision,and supervision decision,which plays an important role in the progress of European clinical medicine.Therefore,researchers in China should draw lessons from these four perspectives and design reasonable research directions and programs.
