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学科主题: 临床医学
题名:
东亚开展国际多中心临床试验现况分析——ClinicalTrials.gov调查结果
其他题名: Current Status of Multinational Clinical Trials in East Asia——Results of the Survey Using Clinical Trials.gov
作者: 姚晨1; 杉野敬一1; 龚倩1; 大桥靖雄1
关键词: 东亚 ; 国际多中心临床试验 ; 临床试验注册 ; East Asia ; Multi-national dinical trial ; Clinical trial registration
刊名: 中国循证医学杂志
发表日期: 2010
DOI: 10.3969/j.issn.1672-2531.2010.02.007
卷: 10, 期:2, 页:122-128
收录类别: 中国科技核心期刊 ; CSCD
文章类型: Journal Article
摘要: 目的 了解在东亚开展的国际多中心临床试验现状.方法 2008年5月8日在Clinical Trials.gov下载有东亚部分国家/地区参加的国际多中心临床试验注册记录,分析其治疗疾病、申办者、开发时期、样本量、研究类型、研究设计等.结果 在ClinicalTrials.gov注册的试验中,中国453个(大陆125个、台湾196个、香港134个)、韩国264个、日本231个.在东亚开展的654个临床试验中307个(47%)是国际多中心临床试验,大多由欧美制药公司如辉瑞、阿斯利康、葛兰素史克、赛诺菲-安万特、百时美施贵宝等实施,主要以治疗癌症、中枢神经疾病、心血管病和感染的药品为主.有198个(65%)是Ⅲ期试验、32个(10%)是上市后试验,其他为Ⅱ期和Ⅰ期试验.双盲试验有190个(62%),其中近半数以安慰剂为对照.中国大陆开展的临床试验特点:①多个医院参加的大样本试验占多数,②以Ⅲ期试验为主,③无Ⅰ期试验.在中国台湾、中国香港和韩国开展的临床试验特点:①大多为国际多中心临床试验(中国台湾占84%、中国香港占93%、韩国占72%),②相互间共同参加的大规模试验很多.在日本开展的临床试验中国际多中心临床试验只占17%.大规模试验数少.结论 欧美制药企业的介入促进了东亚的国际多中心临床试验的发展.药品开发过程受各国/地区药品审批法规制度的影响. Objective To know the current status of multinational clinical trials(MNCTs)in East Asia,and to find the characters of MNCTs in countries/regions.Methods We downloaded the trial records of East Asia on May 8,2008 from Clinical Trials.gov and analyzed the data.Results The number of clinical trials sponsored by industry was 125 in China Mainland,196 in Taiwan,134 in Hong Kong,264 in Korea,and 231 in Iapan,respectively.Ofthe total 654 clinical trials in East Asia,307(47%)trials were MNCTs,most of which were conducted by Euro-American pharmaceutical companies,such as Pfizer,AstraZeneca,GlaxoSmithKline,Sanofi-Aventis and Bristol-Myers Squibb.Main therapeutic areas were cancer,followed by CNS diseases,cardiovascular diseases,infectious diseases,diabetes meUitus and respiratory diseases.Trials in phase Ⅲ were 198(65%),in phase Ⅳ 32(10%),others in phase Ⅱ or Ⅰ.One hundred and ninety trials(62%)were double-blind clinical trials,about half of them using placebo.The characters of clinical triak in China were:①Most of MNCTs were large scale trials with big sample size and many study sites;②Most of local trials were phase Ⅲ trials;③There were no phase Ⅰ trials.The characters in Taiwan,Hong Kong and Korea were:1)Most ofthe trials(84%in Taiwan and 93%in Hong Kong,72%in Korea)were MNCTs,2)A lot of large scale trials were conducted with each other.The characters ofclinical trials in Tapan were:①MNCTs were only 17%,②Large scale trials were fewer.Conclusion In East Asia,MNCTs are developing because of the initiation of the Europe and America pharmaceutical giants.It seems that the regulation in each country influence the development pattern of East Asia.
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/46804
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.北京大学第一医院,北京,100034
2.三菱田边制药株式会社,日本
3.东京大学医学系研究科,日本

Recommended Citation:
姚晨,杉野敬一,龚倩,等. 东亚开展国际多中心临床试验现况分析——ClinicalTrials.gov调查结果[J]. 中国循证医学杂志,2010,10(2):122-128.
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