Reflections on the conduct of cell therapy clinical trials in medical institutes
10.3760/cma.j.cn113565-20220317-00038
- VernacularTitle:医疗机构开展细胞治疗临床试验的思考
- Author:
Ping JI
1
;
Yu SHI
;
Weiwei XU
;
Yongsheng ZHAO
;
Tao WANG
;
Junhui CHEN
;
Yun CHEN
Author Information
1. 深圳北京大学香港科技大学医学中心临床研究所 518036
- Keywords:
Cell therapy;
Patient-centered clinical trials;
Shared decision making
- From:
Chinese Journal of Medical Science Research Management
2023;36(1):2-6
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This paper introduces the concepts of " patient-centered cell therapy research management model", to provide reference for domestic medical institutions which conduct cell therapy clinical trials.Methods:We reviewed and summarized the experiences of conducting cell therapy at Peking University Shenzhen Hospital, including challenges and response plans regarding to the technology assessment, ethical evaluation risks and regulatory compliance. According to which, this paper aims to explore the reflections and practical experience of establishing a patient-centered, multi-stakeholder shared decision-making research management system.Results:The " patient-centered cell therapy research management model" ensures the reliability of research results through multi-stakeholder engagement in decision-making and management, adequate technical evaluation, effective ethical review and harmonized scientific research management, which not only meets the urgent health needs of the patient, but also promotes the standardized development of emerging technologies.Conclusions:The " patient-centered cell therapy research management model" is tailored for the cell therapy research, it is important to promote its further assessment and applications.
