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

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。

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.