中国临床研究助理的生态环境及现场管理组织发展报告  

Cultural environment and development of CRC and SMO in China

作　　者：李树婷 刘洋 高志刚 王月 胡思佳 熊梦桢 高丽星 王哲渊 桂尚苑 所伟[10] 刘燕飞[11] 杨丽[12] 王欣[13] 任科 LI Shu-ting;LIU Yang;GAO Zhi-gang;WANG Yue;HU Si-jia;XIONG Meng-zhen;GAO Li-xin;WANG Zhe-yuans;GUI Shang-yuan;SUO Wei;LIU Yan-fei;YANG Li;WANG Xin;REN Ke(Clinical Research Promotion Funds （ Beijing Century Charity Foundation） , Beijing100062, China;Beijing LinkStart SMO Co. Ltd. , Beijing 100024, China;Beijing CTS Co. Ltd. , Beijing 100024, China;SMO ClinPlus Co. Ltd. , Shanghai 200001 , China;Hangzhou Simo Co. Ltd. , Hangzholz 310051 , China;CCBR（Beijing） Company Ltd. , Beijing 102206, China;NovoTtial Inc. , Beijing 100124, China;Beijing Excellence Angel Medicinal Technological Progress Co Ltd. , Beijing 100054, China;Nanjing SeMoo Medicine Technology Co. Ltd.. Nanjing 210046, China;Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China;Fudan University Shanghai Cancer Center, Shanghai 200433, China;Peking University Third Hospital, Beijing 100191 , China;Beijing Hospital, National Institute on Aging, Beijing 100730, China;Shanghai MedKey Med-Tech Development Co. Ltd. , Shanghai 200025, China)

机构地区：[1]临床研究促进公益基金(北京世纪慈善基金会),北京100062 [2]北京联斯达医药科技发展有限公司,北京100123 [3]北京鼎晖思创医药研究有限公司,北京100024 [4]普蕊斯(上海)医药科技开发股份有限公司,上海200001 [5]杭州思默医药科技有限公司,杭州310051 [6]西斯比亚(北京)医药技术研究有限责任公司,北京102206 [7]北京诺为力创医药科技发展有限公司,北京100124 [8]北京卓越天使医药科技发展有限公司,北京100054 [9]南京西姆欧医药科技有限公司,南京210046 [10]首都医科大学附属北京安贞医院,北京100029 [11]复旦大学附属肿瘤医院,上海200433 [12]北京大学第三医院,北京100191 [13]北京医院,国家老年医学中心,北京100730 [14]上海津石医药科技有限公司,上海200025

出　　处：《中国新药杂志》2018年第11期1266-1272,共7页Chinese Journal of New Drugs

摘　　要：临床研究助理/协调员(CRC)在近几年的新药临床试验中发挥越来越重要的作用,承担了绝大部分的非医学判断工作,成为研究者、申办方和研究中心之间的重要纽带,成为加快临床试验、保证试验质量的重要力量。CRC是一个新兴职业,加强对CRC的关心和理解对这个队伍的健康发展十分重要。本文以2014年"中国CRC之家"成立以来进行的10次问卷调查结果为依据,对不同年度的数据进行对比和分析,从11个方面对CRC和现场管理组织(SMO)的生态环境进行展示,包括CRC/SMO在中国的发展过程、人员构成情况及在全国主要城市的分布、CRC的人事管理和SMO运营模式、项目承担情况和工作负荷、人员培养的主要方式、薪酬情况和满意度、CRC的职业发展及对未来前景的信心、目前的困难和亟待解决的问题、行业活动和今后的发展趋势等,全方位勾画出CRC的群体状态,不仅让更多的研究者对他们的助手有所了解,而且让整个制药行业都来关注CRC,共同培养这支年轻的队伍,让CRC这个职业在更好的环境中成长和发展,成为中国临床试验的坚定基石。Clinical research assistants/coordinators（ CRC） have played an increasingly important role inthe new drugs clinical trials in recent years. They have undertaken most of the non-medical judgment work,become an important link among investigators,sponsors and clinical trial centers,and been an important force in accelerating enrollment and ensuring quality of clinical trials. CRC is a new career,so it is very important for us to have more concern and understanding in order to develop this team successfully. Based on the results of 10 questionnaires conducted since establishment of ＂China CRC Home ＂in 2014,comparing and analyzing the data of different years,this paper describes the culture environment of CRC and SMO（ site management organization,SMO） from11 aspects including CRC/SMO＇s development track,their personnel composition and distribution in major cities,CRC＇s personnel management and SMO＇s commercial mode,major ways of personnel training,and so on. The status of CRC is outlined in all aspects in this paper. The aim is not only letting more investigators know their assistants,but also paying more attention to the cultivation of CRC at that the whole pharmaceutical industry. So that this young team can grow and develop in a better environment and become a strong basic force for new drugs development in China.

关 键 词：临床研究助理 临床研究协调员 临床试验 临床试验管理规范 新药研发 机构管理 现场管理组织 

分 类 号：R95[医药卫生—药学]