医疗机构加强干细胞临床研究风险防控的策略探讨
Strategies for medical institutions to strengthen the risk prevention and control of stem cell clinical research
郑天慧 1汤红明 1何斌 1赵庆辉 1李佳潞 1刘中民1
作者信息
- 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
- 折叠
摘要
目的 探讨医疗机构开展干细胞临床研究风险防控策略,以保证干细胞临床研究的安全性和有效性.方法 对医疗机构开展干细胞临床研究时面临的政策风险、研究机构风险、干细胞制剂管理风险和受试者安全性风险进行总结分析.结果 对干细胞临床研究中的风险,建议从关注政策动态与遵守法规要求、健全机构建设与完善质量管理、加强制剂审查与规范院内流转、强化受试者监测与制定应急预案等进行防控.结论 通过实施上述风险防控策略,可避免或有效减少干细胞临床研究中可能出现的风险,保护受试者的安全和权益,保证临床研究的质量和效率,亦可为医疗机构开展干细胞临床研究的风险防控管理提供参考和借鉴,助推干细胞领域健康、持续发展.
Abstract
Objective To explore the risk prevention and control strategies of stem cell clinical research in medical insti-tutions,so as to ensure the safety and effectiveness of stem cell clinical research.Methods The policy risks,research institu-tion risks,stem cell preparation management risks,and subject safety risks faced by medical institutions in conducting stem cell clinical research were summarized and shared.Results In order to prevent and control the risks in stem cell clinical research,it was suggested to pay attention to policy dynamics and comply with regulatory requirements,improve institution construction and the whole process quality management system,strengthen the quality review of preparations and standardize the transfer of preparations within the hospital,strengthen the safety monitoring of subjects and formulate emergency plans for adverse reac-tions.Conclusions By implementing the above risk prevention and control strategies,we can avoid or effectively reduce the risks that may occur in stem cell clinical research,protect the safety and rights of subjects,and ensure the quality and efficiency of clinical research.This can provide reference and reference for the risk prevention and control management of medical institu-tions to carry out stem cell clinical research,and promote the healthy and sustainable development of stem cell field.
关键词
干细胞临床研究/医疗机构/风险识别/风险防控Key words
Stem cell clinical research/Medical institutions/Risk identification/Prevention and control of risk引用本文复制引用
基金项目
上海市高校Ⅳ类高峰学科建设建设项目()
上海市医院协会医院管理研究基金(X2021057)
上海市标准化试点项目(S23-04-007)
出版年
2024
NETL
NSTL
万方数据