基于一项研究者发起的肾移植多中心前瞻性临床研究的组织设计和实施流程管理探讨  

Organization design and implementation process management based upon an investigator-initiated multi-center prospective clinical trial of kidney transplantation

作　　者：王思君 陈慧俊 匡培丹 吴晴航 胡梦娜 陈刚[1] 张雷 朱兰[1] Wang Sijun;Chen Huijun;Kuang Peidan;Wu Qinghang;Hu Mengna;Chen Gang;Zhang Lei;Zhu Lan(Institute of Organ Transplantation,Affiliated Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Key Laboratory of Organ Transplantation,Ministry of Education,NHC Key Laboratory of Organ Transplantation,Key Laboratory of Organ Transplantation,Chinese Academy of Medical Sciences,Wuhan 430030,China;Department of Organ Transplantation,First Affiliated Hospital,Naval Medical University,Shanghai 200433,China;Department of Kidney Transplantation,First Affiliated Hospital,Xi'an Jiaotong University School of Medicine,Xi'an 710061,China;Center of Nephrology,First Affiliated Hospital,College of Medicine,Zhejiang University,Hangzhou 310003,China;Organ Transplantation Center,Institute of Urology,West China Hospital,Sichuan University,Chengdu 610044,China)

机构地区：[1]华中科技大学同济医学院附属同济医院器官移植研究所,器官移植教育部重点实验室,国家卫生健康委员会器官移植重点实验室,中国医学科学院器官移植重点实验室,武汉430030 [2]海军军医大学第一附属医院器官移植科,上海200433 [3]西安交通大学医学院第一附属医院肾移植科,西安710061 [4]浙江大学医学院附属第一医院肾脏病中心,杭州310003 [5]四川大学华西医院泌尿外科,泌尿外科研究所,器官移植中心,成都610044

出　　处：《中华器官移植杂志》2024年第7期476-480,共5页Chinese Journal of Organ Transplantation

基　　金：中国医学科学院中央级公益性科研院所基本科研业务费专项(2023-PT320-07)。

摘　　要：结合"细环病毒载量在中国肾移植受者免疫抑制治疗中的动力学变化:多中心前瞻性观察性双盲队列研究"具体策划和实施过程中的经验与教训,探讨研究者发起的肾移植多中心前瞻性临床研究在我国的发展现状与主要困难,并就相关研究组织设计与实施流程管理过程中需要注意的问题进行讨论,以提高相关研究的实施质量。Based upon the experiences of planning and implementation of"Dynamic changes of Torque Teno virus load in Chinese renal transplant recipients with immunosuppressive therapy:A multi-center prospective observational double-blind cohort study",this article explored the current status and major difficulties of investigator-initiated multi-center prospective clinical trials of kidney transplantation in China.Various issues of organization design and implementation process management were discussed for enhancing the quality of implementing the relevant trials.

关 键 词：肾移植 多中心临床研究 前瞻性研究 研究者发起的临床研究 

分 类 号：R699.2[医药卫生—泌尿科学]