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强化临床试验过程报告,推进临床试验全程透明化 被引量:7

Strengthen the process report of clinical trials, promote full transparency of clinical trials
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摘要 临床试验透明化进程已走过40余年,试验注册、报告规范的制订、数据共享已成为常规操作或被重视和推动。临床试验过程作为临床试验操作、质量控制的核心环节,对于试验结果的真实性起决定性作用,但目前对临床试验过程的报告尚不够充分。本文归纳了临床试验过程报告的重要意义,同时给出了强化报告的具体措施建议。我们将倡导期刊、报告规范制订者和临床试验注册平台共同协作,强化临床试验过程报告,推进临床试验全程透明化。 The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals,reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials.
作者 董冲亚 阎小妍 田然 卞兆祥 姚晨 DONG Chongya;YAN Xiaoyan;TIAN Ran;BIAN Zhaoxiang;YAO Chen(Peking University First Hospital,Beijing,100034,P.R.China;Peking University Clinical Research Institute,Beijing,100191,P.R.China;School of Chinese Medicine,Hong Kong Baptist University,Hong Kong,999077,P.R.China)
出处 《中国循证医学杂志》 CSCD 北大核心 2018年第7期648-650,共3页 Chinese Journal of Evidence-based Medicine
关键词 临床试验 过程 报告 透明化 临床试验变革 Clinical trial Process Report Transparency Change face of clinical trial
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