中国药物警戒 ›› 2017, Vol. 14 ›› Issue (6): 353-358.

• 法规与管理研究 • 上一篇    下一篇

真实世界证据用于药械监管与卫生决策的机遇与挑战

孙宇昕1,魏芬芳1,2,杨悦1,2,*   

  1. 1 沈阳药科大学工商管理学院，辽宁 沈阳 110016;
    2 国际食品药品政策与法律研究中心，沈阳 110016
  • 收稿日期:2017-05-11 修回日期:2017-08-17 出版日期:2017-06-20 发布日期:2017-08-17
  • 通讯作者: 杨悦，女，教授，博导，药事法规与药品政策。E-mail：yyue315@vip.126.com
  • 作者简介:孙宇昕，女，在读硕士，药事管理。
  • 基金资助:
    国家食品药品监督管理总局课题（20160003）：美国创新药审评制度比较研究。

Opportunities and Challenges for Real World Evidence Applied in Drug Regulation and Health Decision Making

SUN Yu-xin1, WEI Feng-fang 1, 2, YANG Yue1, 2,*   

  1. 1 College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    2 International Food and Drug Policy and Law Center, Liaoning Shenyang 110016, China
  • Received:2017-05-11 Revised:2017-08-17 Online:2017-06-20 Published:2017-08-17

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摘要： 目的 介绍真实世界证据等相关术语的概念、特点和作用，阐述真实世界证据在药械监管与卫生决策的机遇与挑战，为实现医药产品全生命周期监测提出建议，为进一步加强决策的科学性提供参考和思路。 方法 基于国内外文献检索，研究欧美探索真实世界证据应用于药械安全性、有效性、经济性决策的发展历程与具体实践，对比分析我国发展现状；总结我国卫生体制与药械监管发展存在的现状与问题，分析真实世界证据带来的机遇与挑战。 结果与结论 真实世界证据能够为产品全生命周期评价决策提供证据基础，欧美等发达国家目前广泛开展相关应用研究与立法，美国正稳健开发真实世界证据用于监管决策相关政策体系，欧盟将真实世界证据发展与大数据紧密结合在一起，我国在已有探索基础上，应加强国家立法进一步开发RWE的使用价值与使用范围，促进监管部门主动监管模式的建立。

关键词: 真实世界证据, 真实世界研究, 卫生决策

Abstract: Objective To introduce the concept, characteristics and functions of relevant terms such as real-world evidence, expounded the opportunities and challenges of real-world evidence in drug regulation and health decision-making, and put forward some suggestions for realizing the life cycle monitoring of pharmaceutical products, so as to further strengthen the scientific nature of decision-making. Methods Based on comprehensive literature search at home and abroad, this paper studied the real-world study and its’ appliance in the development of drug safety, effectiveness and economic decision-making; summarized the present situation of China's development in this area; made the analysis of the opportunities and challenges of real world evidence. Results and Conclusion Real-world evidence can provide strong support for product lifecycle evaluation in decision-making. Developed countries such as Europe and the United States are currently conducting extensive application research and legislation in this area, while China has been still in the start stage. Therefore, more efforts should be made to further develop RWE in its value exploration and application range expanding, and further promote the establishment of proactive regulatory model of regulatory authorities.

Key words: real-world evidence, real-world research, health decision-making

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