How Real-World Evidence Supports Healthcare Decisions in EU and Its Enlightment to China

摘要

Objective To summarize the concept,background,application value of real-world evidence(RWE)and its enlightenment to China based on the analysis of the information about the RWE supporting health decision in the European Union,and to provide a reference for Chinese health departments.Methods Through literature research and data collection,the requirements of EU countries,especially some typical countries,for clinical evidence in health decision were obtained,and the application of RWE in supporting health decision in EU was analyzed with specific cases.Results and Conclusion RWE plays an increasingly important role in supplementing the evidence base of clinical trials,verifying the safety and effectiveness of medical devices,and accelerating the market access of new drugs.With the improvement of RWE quality,RWE will not only be used in the evaluation of biological agents and chemical drugs,but also play an important role in the evaluation of traditional Chinese medicine and the post-marketing evaluation of medical devices.