临床研究协调员在大型针刺临床试验中的角色与实践

The Practice and Role of Clinical Research Coordinator in Large Sample and Multi-center Acupuncture Clinical Trials

中国近年来开展了很多包括药物临床试验在内的临床科研项目,而且很多都是大样本多中心的RCT。但是由于国内缺乏专职临床研究协调员(Clinical Research Coordinator,CRC),临床研究协调员一般由医生充当,存在诸多弊端。本文介绍了国内外CRC发展现状,描述了黑龙江"国家中医临床研究基地"妇科实施的一项针刺联合克罗米芬治疗多囊卵巢不孕症的多中心、大样本、随机对照双盲临床试验(PCOSAct:Acupuncture and Clomiphene Citrate for Live Birth in Polycystic Ovary Syndrome)中临床研究协调员的工作内容,详细阐述了其在此项临床试验中的角色定位及分工,分析医疗系统与研究护士作为临床研究协调员的利弊,以期为国内临床研究的发展以及研究护士的培养提供参考和借鉴。

In recent years, there were increasing number of clinical research projects including medicine clinical trials were car- ried out in China, and many of them were large sample and multi-center RCT. As there were short of clinical research coordinator in China, doctors usually acted as CRC, while it caused various problems. This article introduced status quo of CRC at home and abroad, and described responsibility of CRC in the large sample, multi-center and double-blind acupuncture RCT which researched on acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome and undertaken by the department of gynaecology of National TCM Clinical Researching Base in Heilongjiang province. We elaborated the role of CRC in this triM, and analyzed pros and cons for medical personnel and research nurse as a CRC. It was aimed at providing references for the developing of clini- cal researches as well as training research nurses.