TY - JOUR
T1 - Regulatory readiness to facilitate the appropriate use of innovation in clinical trials
T2 - The case of decentralized clinical trial approaches
AU - de Jong, Amos J
AU - Zuidgeest, Mira G P
AU - Santa-Ana-Tellez, Yared
AU - de Boer, Anthonius
AU - Gardarsdottir, Helga
N1 - Publisher Copyright:
© 2024 The Author(s)
PY - 2024/11
Y1 - 2024/11
N2 - Methodological and operational clinical trial innovation is needed to address key challenges associated with clinical trials, including limited generalizability and (s)low recruitment rates. In this article, we discuss how appropriate implementation of innovative clinical trial approaches can be facilitated by a timely identification of, and response to, emerging situations and innovation by regulators (i.e. regulatory readiness) using decentralized clinical trial (DCT) approaches - in which trial activities are moved closer to participants and away from the investigative sites - as a case study example. Specifically, we discuss how explorative research (e.g. using regulatory sandboxes) can enable the collection of data on the usefulness of DCT approaches. Additionally, we argue that DCT approaches should be evaluated similarly to conventional clinical trials.
AB - Methodological and operational clinical trial innovation is needed to address key challenges associated with clinical trials, including limited generalizability and (s)low recruitment rates. In this article, we discuss how appropriate implementation of innovative clinical trial approaches can be facilitated by a timely identification of, and response to, emerging situations and innovation by regulators (i.e. regulatory readiness) using decentralized clinical trial (DCT) approaches - in which trial activities are moved closer to participants and away from the investigative sites - as a case study example. Specifically, we discuss how explorative research (e.g. using regulatory sandboxes) can enable the collection of data on the usefulness of DCT approaches. Additionally, we argue that DCT approaches should be evaluated similarly to conventional clinical trials.
KW - clinical trial innovation
KW - decentralized clinical trials
KW - regulation
KW - regulatory readiness
KW - regulatory science
UR - http://www.scopus.com/inward/record.url?scp=85204716854&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2024.104180
DO - 10.1016/j.drudis.2024.104180
M3 - Article
C2 - 39284522
SN - 1359-6446
VL - 29
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 11
M1 - 104180
ER -