摘要
目的 探讨国内建立区域性临床研究整合平台的可行方案,为研究者发起的临床研究(investigator initiated trial,IIT)提供数据支持。方法 总结国内外各类临床研究平台建设现状,以此为改进依据介绍上海交通大学医学院人工智能临床研究平台建设情况。结果 人工智能临床研究平台涵盖医学院附属医院的业务库文字及影像专病数据,支持回顾性与前瞻性临床研究,但在数据使用的伦理考量与共享机制等管理方面仍需要实践探索。结论 合规的区域性临床研究整合平台可支持科研人员发现临床问题、探索或验证临床假设,为开展多中心、大规模的IIT打下良好的数据基础。
Objective To explore a feasible solution for establishing a regional clinical research integration platform in China to provide data support for investigator initiated trials(IIT).Methods To summarize the current situation of the construction of various clinical research platforms at home and abroad,and introduce the construction of the Artificial Intelligence Clinical Research Platform of Shanghai Jiao Tong University School of Medicine based on this improvement.Results The artificial intelligence clinical research platform covers business repository text and imaging-specific data of the medical school hospitals and supports retrospective and prospective clinical research,but still needs practical exploration in the management of ethical considerations and sharing mechanism of data use.Conclusion A compliant regional clinical research integration platform can support researchers in identifying clinical questions,exploring or validating clinical hypotheses,and laying a good data foundation for conducting multi-center and large-scale IIT.
作者
林毅
渠田田
钱碧云
吕文文
俞章盛
冯铁男
LIN Yi;QU Tiantian;QIAN Biyun;LYU Wenwen;YU Zhangsheng;FENG Tienan(Shanghai Gaintion Electronic Technology Co.,Shanghai 200023,China;Clinical Research Institute,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Shanghai Clinical Research Promotion and Development Center,Shanghai Shenkang Hospital Development Center,Shanghai 200041,China;School of Mathematical Sciences,Shanghai Jiao Tong University,Shanghai 201100,China)
出处
《中国现代医生》
2023年第29期106-109,共4页
China Modern Doctor
关键词
研究者发起的临床研究
临床研究平台
专病数据库
管理机制
Investigator initiated trial
Clinical research platform
Specialized disease database
Management Mechanism