肿瘤专科医院Ⅰ期临床研究病房的建设与实践

Construction and Practice of Phase Ⅰ Clinical Trial Ward in Cancer Hospital

目的总结湖南省肿瘤医院构建肿瘤专科特色Ⅰ期临床研究病房的实践经验,为正在建设Ⅰ期临床研究病房的医疗机构提供参考和借鉴。方法我院Ⅰ期临床研究病房以肿瘤受试者为中心,以多学科团队协作模式进行肿瘤受试者的全病程管理,建立高效的管理体系来保障Ⅰ期临床研究病房的建设,主要内容包括病区管理、受试者管理、研究团队管理、质量控制、信息化建设等。结果Ⅰ期临床研究病房成立以来,病房在研项目160余项,Ⅰ期病房方案违背率低于1%,采血及处理生物样本超窗发生率均低于0.8%,受试者护理不良事件发生率低于0.45%,第三方测评满意度均高于96%,肿瘤受试者和家属满意度增高。结论我院基于肿瘤专科特色建设高效的Ⅰ期临床研究病房管理体系,搭建了湖南省临床试验培训、科研、信息交流平台,其服务模式和管理体系可推广至其他医院,进一步推动临床研究在全国范围的发展。

Objective To summarize the experience of constructing phase I clinical trial ward with tumor speciality characteristics in Hunan Cancer Hospital, so as to provide reference for the building of phase I clinical trial ward in medical institutions. Methods The phase I clinical trial ward of our hospital was subject-centered and managed by a multidisciplinary team. An efficient management system was developed to ensure the construction including ward management, subject management, research team management, quality control, information construction, etc. Results The establishment of phase I clinical trial ward gave full play to the demonstration role of tumor hospital. There were more than 160 ongoing scientific research programs. The rate of protocol violation was <1%;blood sampling and biological sample time window <0.8%;the incidence of nursing adverse event <0.45% and the satisfaction rate of tumor subjects and family members from third party evaluation >96%. Conclusion An efficient phase I clinical trial ward management system is established based on the characteristics of tumor specialty, and a clinical trial training, scientific research and exchange platform in Hunan Province is built. Its service mode and management system can be promoted to other hospitals to further promote the development of clinical trial throughout the country.