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临床试验原始数据透明化与共享:关于医学研究伦理的哲学命题及其对临床试验的意义

Transparency and sharing individual participant data of clinical trials:a philosophical proposition about the medical study ethics and implications for clinical trials

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【作者】 吴泰相; 卞兆祥; 李幼平; 商洪才; 姚新生;

【Author】 WU Taixiang;BIAN Zhaoxiang;LI Youping;SHANG Hongcai;YAO Xinshen;Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University;School of Chinese Medicine, Hong Kong Baptist University;Dongzhimen Hospital, Beijing University of Chinese Medicine;College of Pharmacy, Jinan University;

【机构】 四川大学华西医院中国循证医学中心; 香港浸会大学中医药学院; 北京中医药大学东直门医院; 暨南大学药学院;

【摘要】 临床试验透明化,包括临床试验注册、无偏倚地报告结果和共享原始数据,是继临床流行病学和循证医学之后临床医学领域又一革命性的理念。共享原始数据是关于医学研究伦理的哲学命题,正在引领临床试验变革,并将建立新的临床试验价值观和规则。从临床研究的本质目的出发,临床试验原始数据应是全社会的公产,共享原始数据是对受试者奉献的最好尊重,是临床试验变革的关键之一。

【Abstract】 Clinical trial transparency, include clinical trial registration, unbiased reporting results and sharing individual participant data(IPD), is one of the most important revolutionary concepts following clinical epidemiology and evidence-based medicine in the medical field. Sharing IPD is a medical ethics issue reflected a new sense of worth and constructing new rules of clinical trials. Our viewpoint is that from the essential purpose of clinical research, IPD is a social public property. Sharing IPD is a one of the best ways for respecting the contributions of the participants, and one of the keys for changing face of clinical trials.

  • 【文献出处】 中国循证医学杂志 ,Chinese Journal of Evidence-Based Medicine , 编辑部邮箱 ,2018年06期
  • 【分类号】R-05
  • 【被引频次】24
  • 【下载频次】401
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