摘要
随着近年来中国临床研究的快速增长,研究者发起的临床研究(IIT)成为关注热点。与药企资助的临床试验相比,限于研究者的经验和法规环境等因素,IIT的实施面临很多实际困难。为了解我国医疗机构中对IIT项目的管理现况,笔者通过网络问卷的方式对来自于231家医疗机构的259位国内医疗机构相关管理部门和临床一线的工作人员进行调查,分别涉及临床研究的审评、资金来源、项目管理、伦理审批、研究助理管理等方面数据,并对部分问题进行了交叉分析。从调查结果可见,目前中国的IIT项目在资金支持、专职人员配备和法规健全等方面有较大发展空间。
With the rapid development of clinical trials in China in recent years, management of investigator initiated trials（ IIT） became a focusing point. Compared with the trials sponsored by pharmaceutical companies, IIT are facing practical challenges in China due to the lack of experience by investigator and immature regulatory circumstances. In order to understand the overall picture of IIT management in local medical institutions, an online questionnaire was conducted for 259 responses from 231 medical institutions from the staffs who were mainly responsible for the clinical trial management and scientific research based in the clinical facilities. The data from the following aspects were received, including study concept development and protocol design, funding resources, management of pilot projects, ethical review and research staff management. Some cross-examined data were also made. In China, three key factors are important to the improved management on IIT, including funding support, personnel support and regulatory guidance.
作者
曹烨
王欣
曹玉
宋福鱼
李可欣
洪明晃
CAO Ye;WANG Xin;CAO Yu;SONG Fu-yu;LI Ke-xin;HONG Ming-huang(Department of Clinical Research~National Clinical Trials Institute,State Key Laboratory（SKL）of Oncology in South China ＆ Sun Yatsen University Cancer Center,Guangzhou GUANGDONG 510060,China;National Center of Gerontology,Clinical Trial Center/National Clinical Trials Institute of Beijing Hospital,BEIJING 100730,China;National Clinical Trials Institute,Affiliated Hospital of Qingdao University,Qingdao SHANDONG 266003,China;Center for Food and Drug Inspection,China Food and Drug Administration,BEIJING 100061,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2018年第7期395-400,共6页
Chinese Journal of New Drugs and Clinical Remedies
关键词
研究者发起的临床研究
问卷调查
研究人员
机构管理小组
investigator initiated trials
questionnaires
research personnel
institutional management teams
作者简介
曹烨，女，助理研究员，博士，主要从事肿瘤临床、临床研究安全性评价和临床研究管理的研究，E-mail：caoye@sysucc．org．cn
