机构备案制下临床试验工作开展的几点思考  

Several thoughts on conduction of clinical trials under institution registration system

作　　者：张莹莹 李晶[1] 李明[1] 杜雅薇[1] 朱玉梅[1] 吴圣贤[1] ZHANG Ying-ying;LI Jing;LI Ming;DU Ya-wei;ZHU Yu-mei;WU Sheng-xian(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东直门医院,北京100700

出　　处：《中国新药杂志》2022年第6期586-589,共4页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09304019):中药新药“病-证-症关联”临床评价技术平台。

摘　　要：药物/医疗器械临床试验机构备案制的实施,有效地促进了临床试验资源整合,给各方带来机会的同时,也对临床试验提出了各种挑战。如何在众多机构中被申办方选择,成为临床试验项目的承担/参与单位,如何在法律法规框架下有效地实施、且保质保量地完成项目研究工作是本研究关注的内容。结合目前的形势和工作实施的实际情况,本研究从管理层面、实施层面及存在的问题等方面提出几点思考和建议,以期为业界提供参考。The implementation of the registration system of drug/medical device clinical trial institutions has effectively promoted the integration of clinical trial resources,brought opportunities to all parties,but also put forward various challenges to clinical trials.How to be selected by the sponsor among many organizations to become the undertaker/participant of the clinical trial project?How to implement the project effectively under the framework of laws and regulations and complete the project content with quality and quantity guaranteed?Combined with the current situation and the actual experience of work implementation,this article put forward some thoughts and suggestions from the management level,implementation level and existing problems,in order to provide reference for peers and provide useful help for future work.

关 键 词：机构备案 临床试验 存在问题:应对策略 

分 类 号：R95[医药卫生—药学]