TY - JOUR
T1 - Pragmatic randomized trials in drug development pose new ethical questions
T2 - A systematic review
AU - Kalkman, Shona
AU - van Thiel, Ghislaine J M W
AU - Grobbee, DE
AU - van Delden, Johannes J M
PY - 2015/7
Y1 - 2015/7
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84925434900&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2015.03.005
DO - 10.1016/j.drudis.2015.03.005
M3 - Article
C2 - 25794600
AN - SCOPUS:84925434900
SN - 1359-6446
VL - 20
SP - 856
EP - 862
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 7
ER -