摘要
真实世界研究(RWS)不仅可以用于支持处方药(Rx),也可以用于非处方药(OTC)的新药研发及医疗决策,但关于OTC领域的RWS研究仍然极其有限。本文介绍了真实世界数据(RWD)在OTC领域中的应用,并以处方药为参照对象,对OTC领域中RWD的相关数据来源进行详细分析,揭示了RWD在Rx-OTC转化、药品上市后安全性监管、有效性补充证明等多方面的发展潜力及治理要点。
Real-world study(RWS)is commonly used to support the R&D of new drugs and medical decision making in either prescription drugs(Rx)or over the counter(OTC)drugs,but it is rarely mentioned in the latter.Based on the characteristics of real world data(RWD),this article introduces the application of real-world data in OTC drugs,analyzes the relevant sources of RWD data in OTC drugs compared with that of Rx drugs.We also summarizes the key application and governance of RWD in the fields of Rx-OTC switch,post-marketing safety regulation,and supplemental proof of effectiveness.
作者
章颖
王闻雅
ZHANG Ying;WANG Wen-ya(Institute of Digital Technology and Law,China University of Political Science and Law,Beijing 100088,China;Beijing Tsinghua Changgeng Hospital,Beijing 100084,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第23期2350-2354,共5页
Chinese Journal of New Drugs
基金
科技部“政府间国际科技创新合作”重点专项资助项目(2021YFE0192400)。
