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

Translated title of the contribution: Transparency and sharing individual participant data of clinical trials: A philosophical proposition about the medical study ethics and implications for clinical trials

吴泰相*, 卞兆祥, 李幼平, 商洪才, 姚新生

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

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.

Translated title of the contributionTransparency and sharing individual participant data of clinical trials: A philosophical proposition about the medical study ethics and implications for clinical trials
Original languageChinese (Simplified)
Pages (from-to)538-542
Number of pages5
Journal中国循证医学杂志
Volume18
Issue number6
DOIs
Publication statusPublished - Jun 2018

Scopus Subject Areas

  • Medicine(all)

User-Defined Keywords

  • Changing face of clinical trials
  • Clinical trial transparency
  • Sharing individual participant data
  • Social public property

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