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 Europe...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.展开更多
目的:剖析研讨抗血管内皮生长因子(VEGF)药物用于年龄相关性黄斑变性(AMD)的研究现状和研究热点,客观反映相关国家/地区、机构和作者在抗VEGF药物治疗AMD研究领域的学术影响力和科研实力。方法:分别检索Web of Science(检索时限为建库至...目的:剖析研讨抗血管内皮生长因子(VEGF)药物用于年龄相关性黄斑变性(AMD)的研究现状和研究热点,客观反映相关国家/地区、机构和作者在抗VEGF药物治疗AMD研究领域的学术影响力和科研实力。方法:分别检索Web of Science(检索时限为建库至2019年4月26日)和CNKI(检索时限为建库至2019年4月2日),搜集有关抗VEGF药物用于AMD的研究。统计发文较多的国家/地区、作者、研究机构、期刊、年发文量、被引用频次和发文量排名情况,并使用HistCite和Citespace软件创建引证关系图和关键词共现时区视图。结果:共检索到2 931篇外文文献,2014年发文数最多,占总数的10.5%;发文量最多的国家是美国,占总数的32.9%。在CNKI共检索到中文期刊248篇,目前2018年发文最多,为48篇。结论:近年来抗VEGF药物用于治疗AMD的研究发展迅速,中国研究者进入这一领域较晚,但近年来研究的数量和深度都在不断增加。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 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.
文摘目的:剖析研讨抗血管内皮生长因子(VEGF)药物用于年龄相关性黄斑变性(AMD)的研究现状和研究热点,客观反映相关国家/地区、机构和作者在抗VEGF药物治疗AMD研究领域的学术影响力和科研实力。方法:分别检索Web of Science(检索时限为建库至2019年4月26日)和CNKI(检索时限为建库至2019年4月2日),搜集有关抗VEGF药物用于AMD的研究。统计发文较多的国家/地区、作者、研究机构、期刊、年发文量、被引用频次和发文量排名情况,并使用HistCite和Citespace软件创建引证关系图和关键词共现时区视图。结果:共检索到2 931篇外文文献,2014年发文数最多,占总数的10.5%;发文量最多的国家是美国,占总数的32.9%。在CNKI共检索到中文期刊248篇,目前2018年发文最多,为48篇。结论:近年来抗VEGF药物用于治疗AMD的研究发展迅速,中国研究者进入这一领域较晚,但近年来研究的数量和深度都在不断增加。
