临床试验原始数据透明化与共享-中国临床试验注册中心.PDF

• 538 • CHINESE JOURNAL OF EVIDENCE-BASED MEDICINE, Jun. 2018, Vol. 18, No.6   ·中国临床试验变革· 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 1 2 1 3 4 吴泰相 ，卞兆祥，李幼平，商洪才，姚新生 1. 四川大学华西医院中国循证医学中心（成都  610041 ） 2. 香港浸会大学中医药学院（中国香港  999077 ） 3. 北京中医药大学东直门医院（北京  100029 ） 4. 暨南大学药学院（广州  510632 ） 【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。 【关键词】   临床试验透明化；个体数据共享；社会公共财产；临床试验变革 Transparency and sharing individual participant data of clinical trials: a philosophical proposition about the medical study ethics and implications for clinical trials 1 2 1 3 4 WU Taixiang , BIAN Zhaoxiang , LI Youping , SHANG Hongcai , YAO Xinshen 1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China 2. Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hongkong, 999077, P.R.China 3. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100029, P.R.China 4. College of Pharmacy, Jinan University, Guangzhou, 510632, P.R.China Corresponding author: WU Taixiang, Email: chictr@; LI Youping, Email: yzmylab@ 【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 r