Transformation of the key role and related responsibilities of stem cell clinical research in the context of double filling system and the corresponding strategies
10.3760/cma.j.cn113565-20200705-00222
- VernacularTitle: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
- Author:
Bin HE
1
;
Qinghui ZHAO
;
Erpeng JIANG
;
Wenjun LE
;
Hongming TANG
;
Zhongmin LIU
Author Information
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
- Keywords:
Double filling system;
Stem cell clinical research;
Clinical research role
- From:
Chinese Journal of Medical Science Research Management
2021;34(3):172-175
- CountryChina
- Language:Chinese
-
Abstract:
Objective:According to the regulatory requirement in China, double filing system including institutional filing and project 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 trials. Based on the analysis of the main roles and 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 responsibilities of stem cell clinical research in the context of double filing system, and conducts analysis on the main-role construction of stem cell clinical research.Results:Combining the institutional practical experience of conducting and managing stem cell clinical 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:It is recommended to strengthen the construction of the main roles and responsibilities of stem cell clinical research, which has important practical significance for promoting stem cell clinical research and accelerating the clinical translation and application of stem cells.
