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国际临床试验注册概述
引用本文:于河,刘建平.国际临床试验注册概述[J].中西医结合学报,2007,5(3):234-242.
作者姓名:于河  刘建平
作者单位:北京中医药大学循证医学中心,北京,100029
基金项目:国家重点基础研究发展计划(973计划)
摘    要:临床试验是进行医学研究的重要手段,目前为止,只有部分临床试验在不同性质的注册机构进行了注册。临床试验注册能够避免临床研究中的各种偏倚以及由于重复研究而造成的浪费,有利于开展循证医学研究,进而促进人类健康事业的进步。因此,临床试验进行注册的重要性和必要性已日益显现。本文就临床试验注册的定义、原因、要求、内容、历史与现状进行了概述,并详细介绍了重要的国际临床试验注册机构。通过分析临床试验注册的历史与现状,提出未来的临床试验注册将趋向于透明化、强制性和综合性的方向发展。

关 键 词:临床试验  国际机构  循证医学
文章编号:1672-1997(2007)03-0234-09

A review of international clinical trial registration
He YU,Jian-ping LIU.A review of international clinical trial registration[J].Journal of Chinese Integrative Medicine,2007,5(3):234-242.
Authors:He YU  Jian-ping LIU
Institution:Evidence-based Chinese Medicine Centre for Clinical Research and Evaluation, Beijing University of Chinese Medicine, Beijing 100029, China
Abstract:Clinical trials play a critical role in medical research.However,only a few clinical trials conducted at present have been registered at various clinical trial registries.Clinical trial registration can prevent bias in these registered trials effectively and avoid unnecessary waste of resources due to meaningless repeats.Moreover,it will benefit the development of evidence-based medicine,and promote human welfare.Great attention has been paid to the importance and necessity of clinical trial registration.This review briefly introduced the definition,justification,contents,history, current status of clinical trial registration,and introduced the information regarding important international clinical trial registries in detail.Clinical trial registration should be developed toward a transparent,compulsory and comprehensive stage.
Keywords:clinical trials  international agencies  evidence-based medicine
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