我国细胞治疗临床研究管理现状及对策探讨

Discussions on Regulatory Management Status Quo and Strategies on Clinical Trials of Cell Therapy in China

我国细胞治疗临床研究数量不断增多,使监管部门和研究机构在细胞治疗管理上不断面临新的挑战。该文通过分析我国细胞治疗临床研究的管理现状及存在的问题,探讨健全我国细胞治疗监管和医疗机构内部管理的措施。通过明确各级监管部门的监管职责、加强卫生行政管理部门的日常监管力度;医疗机构内部理清不同类别研究项目的管理机制,对不同类别的项目进行分类管理,避免技术滥用;研究合作各方应建立健全质量管理体系和风险防控预案、并加强研究者的法规和技术培训。

With the increasing number of clinical trials on cell therapy in China, regulatory authorities and medical institutes are facing new challenges in cell therapy management. Currently, there are no specific national regulations or guidelines on whether cell therapy should be classified as new technologies or new drugs, which brings management issues to medical institutions and enterprises, such as cell therapy abuse, non-standardized clinical research, and low risk control awareness of researchers. The author analyses the causes of these problems and puts forward corresponding strategies in order to promote further development of clinical research of cell therapy. On one hand, all the research partners shall establish a sound quality management system and risk control plan. On the other hand, it is necessary to strengthen the regulations and technical training of clinical researchers.