以质量求发展，以服务铸品牌

护理学报 ›› 2022, Vol. 29 ›› Issue (5): 32-36.doi: 10.16460/j.issn1008-9969.2022.05.032

• 护理管理 • 上一篇    下一篇

肿瘤专科医院I期临床研究病房的建设与实践

陈勇a, 彭思意a, 刘小保b, 李坤艳b, 魏涛c, 李旭英d   

  1. 湖南省肿瘤医院 a.早期临床研究中心; b.国家药物临床试验机构办公室; c.麻醉科; d.护理部,湖南 长沙 410013
  • 收稿日期:2021-07-17 出版日期:2022-03-10 发布日期:2022-04-11
  • 通讯作者: 李旭英（1970-）,女,湖南长沙人,博士,主任护师,护理部主任。E-mail: lixuying@hnca.org.cn
  • 作者简介:陈勇（1982-）,女,湖南长沙人,硕士,副主任护师。
  • 基金资助:
    湖南省自然科学基金项目（2020JJ8087）; 湖南省自然科学基金-科药联合基金（2020JJ9042）

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

CHEN Yonga, PENG Si-yia, LIU Xiao-baob, LI Kun-yanb, WEI Taoc, LI Xu-yingd   

  1. a. Early Clinical Trial Center; b. GCP Office; c. Dept. Of Anesthesiology; d. Dept. of Nursing Administration, Hunan Cancer Hospital, Changsha 410013, China
  • Received:2021-07-17 Online:2022-03-10 Published:2022-04-11

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摘要： 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。

关键词: 临床试验, I期临床研究病房, 肿瘤护理, GCP

Abstract: 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.

Key words: clinical trial, I clinical trial ward, oncology nursing, GCP

中图分类号: 

  • R473.73
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