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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
【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