双备案制度下干细胞临床研究角色职责的转变及应对策略  

Transformation of the key role and related responsibilities of stem cell clinical research in the context of double filling system and the corresponding strategies

作　　者：何斌[1] 赵庆辉 蒋尔鹏 乐文俊 汤红明[1] 刘中民[1] He Bin;Zhao Qinghui;Jiang Erpeng;Le Wenjun;Tang Hongming;Liu Zhongmin(Translational Medical Center for Stem Cell Therapy&Institute for Regenerative Medicine,Shanghai East Hospital,Tongji University School of Medicine National Stem Cell Translational Resource Center,Shanghai Institute of Stem Cell Research and Clinical Translation,Shanghai Engineering Research Center for Stem Cell ClinicalTreatment,Shanghai 200123,China)

机构地区：[1]同济大学附属东方医院干细胞转化医学产业基地,国家干细胞转化资源库,上海干细胞临床转化研究院,上海市干细胞临床诊疗工程研究中心,200123

出　　处：《中华医学科研管理杂志》2021年第3期172-175,共4页Chinese Journal of Medical Science Research Management

基　　金：张江国家自主创新示范区专项发展资金重大专项(ZJ2018-ZD-004);上海高校Ⅳ类高峰学科建设资助;上海干细胞产业发展战略研究项目(19692115800)。

摘　　要：目的分析和研究干细胞临床研究主要角色职责,探讨双备案制下角色职责转变的应对策略,探索加快推进干细胞临床研究的举措。方法详细梳理与分析双备案制度下干细胞临床研究主要角色的职责变化,并对干细胞临床研究主要角色的建设进行研究。结果结合笔者单位干细胞临床研究管理及实践经验,建议医疗机构从质检平台建设,机构设置及人才培养共3个方面推进干细胞临床研究。结论加强干细胞临床研究主要角色职责建设,对于推动干细胞临床研究,加速干细胞临床转化及应用,具有重要的现实意义。Objective According to the regulatory requirement ir China,double filing system including institutional filing andproject filing is mandated for conducting stem cell clinical research at medical institutions.Thus,the organization and implementation of stem cell clinical research is different from traditional drug clinical trialsBased on the analysis of the main rolesand responsibilities of stem cell clinical research,this article explores countermeasures to promote the legal and regulatory development of stem cell clinical research,Methods This study sorts out and analyzes the changes in the main roles and responsi-bilities of stem cell clinical research in the context of double filing system,and conducts analysis on the main-role constructionof stem cell clinical research,Results Combining the institutional practical experience of conducting and managing stem cellclinical research,three key issues are proposed to promote stem cell clinical research,which including the construction of quality inspection platform,optimizing institutional setting and talent training.Conclusions lt is recommended to strengthen theconstruction of the main roles and responsibilities of stem cell clinical research,which has important practical significance forpromoting stem cell clinical research and accelerating the clinical translation and application of stem cells.

关 键 词：双备案制度 干细胞临床研究 临床研究角色 

分 类 号：R197.323[医药卫生—卫生事业管理]