对研究者发起的临床研究的认识和思考  

Understanding and thinking about investigator-initiated clinical trials

作　　者：杨志敏[1] 耿莹[2] 高晨燕[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038 [2]首都医科大学附属北京安定医院药物临床试验机构,北京100088

出　　处：《中国新药杂志》2014年第4期387-390,共4页Chinese Journal of New Drugs

摘　　要：随着药物研发全球化趋势的加剧和我国药物创新能力的不断增强,近年来我国的临床研究数量呈递增趋势,其中由研究者发起的各类研究已开始占有越来越重要的地位。研究者发起的临床研究是医学研究的重要组成部分,有助于新药或新治疗策略的检验和发展,与制药企业发起的临床试验并行,互为补充。越来越多的中国临床工作者渴望了解这种医学研究方式,并希望参与其中。本文主要以欧美为例,介绍各国的研究者发起临床研究的监管模式和思路,力求为制定和完善我国的相关法律法规体系提供参考。With the intensifying globalization in drug research and development as well as the increasing new drug innovation, the number of clinical studies is growing in China these years. In these studies, the investigator-initiated clinical trials began to take an increasingly significant position. Investigator-initiated clinical trials represent an important portion of medical research, and are a beneficial complement to industry clinical trials in testing and developing the new drugs or devices. More and more Chinese clinical staffs are hoping to know it and get involved. We reviewed the regulatory mode and ideas for investigator-initiated clinical trials in other countries, especially in Europe and America, to provide reference for the development and improvement of relevant laws and regulations in China.

关 键 词：研究者发起 临床研究 法规 监管 

分 类 号：R95[医药卫生—药学]