Pragmatic randomized trials in drug development pose new ethical questions: a systematic review

Drug Discovery Today
Shona KalkmanJohannes J M van Delden

Abstract

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.

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Citations

Aug 24, 2016·Trials·Shona KalkmanUNKNOWN Work Package 3 of the IMI GetReal Consortium
Dec 3, 2016·Journal of Psychopharmacology·Alasdair Breckenridge, Diederick E Grobbee
May 16, 2017·Journal of Clinical Epidemiology·Shona KalkmanUNKNOWN Work Package 3 of the IMI GetReal Consortium
Jul 19, 2017·The AAPS Journal·Simon Tremblay, Rita R Alloway
Dec 25, 2019·Trials·Stuart G NichollsUNKNOWN Ethics of Pragmatic Trials project

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