Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, PO Box 85500, 3508 GA Utrecht, The Netherlands.
Drug Discov Today. 2015 Jul;20(7):856-62. doi: 10.1016/j.drudis.2015.03.005. Epub 2015 Mar 17.
Implementation of pragmatic design elements in drug development could bridge the evidence gap that currently exists between the knowledge we have regarding the efficacy of a drug versus its true, comparative effectiveness in real life. We performed a review of the literature to identify the ethical challenges thus far related to pragmatic trials. The three central ethical questions identified for pragmatic trials are: (i) what level of oversight should pragmatic trials require; (ii) do randomized patients face additional risks; and (iii) is a waiver of informed consent ethically defensible? Despite the fact all reviewed publications dealt with post-launch pragmatic trials, these results could serve as an important starting point for conceptualizing which challenges could potentially arise in the pre-launch setting.
在药物开发中实施实用设计元素可以弥合目前我们对药物疗效的认识与实际生活中真实比较效果之间存在的证据差距。我们对文献进行了回顾，以确定迄今为止与实用试验相关的伦理挑战。为实用试验确定了三个核心伦理问题：（i）实用试验需要什么样的监督水平；（ii）随机患者是否面临额外风险；（iii）放弃知情同意是否在伦理上站得住脚？尽管所有审查的出版物都涉及上市后实用试验，但这些结果可以作为一个重要的起点，用于构想在上市前可能会出现哪些挑战。
