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国外探索性临床研究现状与思考

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新药研发投入不断增加,但产出率却呈现下降趋势.为此,美国、日本、欧洲等多个国家和地区纷纷提出了探索性临床试验的概念,随后ICH发布相关指南为探索性临床试验提供了一个国际统一的监管框架.目前,我国探索性临床试验尚处于起步阶段,本文从不同视角对国外探索性临床试验经验进行总结分析,旨在为探索性临床试验在我国顺利开展提供参考.
Development status and considerations of exploratory clinical research abroad
With the continuous increase in investment in new drug research and development,the output rate has shown a downward trend.To this end,many countries such as Europe,the United States and Japan have put forward the concept of exploratory clinical trials,and then the relevant ICH guidelines provide an international unified regulatory framework for exploratory clinical trials.However,exploratory clinical trials in China are still in their infancy,and this paper summarizes and analyzes the experience of exploratory clinical trials in foreign countries from different perspectives,aiming to provide a reference for the smooth development of exploratory clinical trials in China.

exploratory clinical trialssummarize and analysisdrug discovery technology

任峰、梅蕾蕾、胡千格、李刚

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国家药品监督管理局药品审评检查长三角分中心,上海 201210

上海药品审评核查中心,上海 201203

探索性临床研究 总结分析 药物研发技术

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(23)