我国大规模群体同情用药的伦理管理问题分析和完善建议  

Analysis of ethical management issues and suggestions for improvement of large-scale group compassionate medication in China

作　　者：洪雪[1] 徐文静[2] 李海燕[3] Hong Xue;Xu Wenjing;Li Haiyan(Ethics Office,Research Department,Peking University Third Hospital,Beijing 100191,China;Ethics Office,Beijing Peking University Sixth Hospital,Beijing 100109,China;Clinical Trial Center,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京大学第三医院科研处伦理办,北京100191 [2]北京大学第六医院伦理办,北京100109 [3]北京大学第三医院药物临床试验机构,北京100191

出　　处：《中华医学科研管理杂志》2024年第6期465-469,共5页Chinese Journal of Medical Science Research Management

摘　　要：目的旨在为完善我国应对类似新型冠状病毒肺炎疫情的突发公共卫生事件提供医学科研支撑,助力国家安全巩固和人民卫生健康事业发展。方法笔者结合多年工作经验及与同行的共同研究,从伦理管理角度对我国大规模同情用药这一临床试验的拓展应用方式进行了问题剖析,并提出了合理可行的完善性建议。结果我国大规模同情用药的伦理管理普遍存在问题,但也具备通过管理机制优化解决的可能。结论我们必须以应对下一轮突发公共卫生事件的紧迫感和责任感,不断优化大规模同情用药管理机制,使其成为构筑国家安全和人民健康卫生堡垒的坚强基石。ObjectiveThis study aims to provide medical scientific research support to further improve China′s response to public health emergencies similar to the new coronavirus,and help consolidate national security and the development of people′s health.MethodsCombined with years of work experience and joint research with colleagues,the author analyzed the problems of expanding the application of large-scale compassionate drug use clinical trials in China from the perspective of ethical management,and puts forward reasonable and feasible suggestions.ResultsThere were many problems in the ethical management of large-scale compassionate drug use in our country,but it was possible to solve them through the optimization of management mechanism.ConclusionsWe must respond to the next round of public health emergencies with a sense of urgency and responsibility,and continuously optimize the management mechanism of mass compassionate drug use,so that it can become a strong cornerstone for building national security and people′s health.

关 键 词：大规模群体 同情用药 伦理管理 

分 类 号：R-052[医药卫生]