Premium
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective
Author(s) -
Jong Amos J.,
Rijssel Tessa I.,
Zuidgeest Mira G. P.,
Thiel Ghislaine J. M. W.,
Askin Scott,
FonsMartínez Jaime,
De Smedt Tim,
Boer Anthonius,
SantaAnaTellez Yared,
Gardarsdottir Helga
Publication year - 2022
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.2628
Subject(s) - european union , clinical trial , diversity (politics) , perspective (graphical) , medicine , business , political science , computer science , pathology , artificial intelligence , law , economic policy
Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in clinical trials by moving trial activities to participants’ homes and local surroundings. In this study, we conducted semi‐structured interviews with 20 European regulators to identify regulatory challenges and opportunities for the implementation of DCTs in the European Union. The key opportunities for DCTs that were recognized by regulators include a reduced participation burden, which could facilitate the participation of underserved patients. In addition, regulators indicated that data collected in DCTs are expected to be more representative of the real world. Key challenges recognized by regulators for DCTs include concerns regarding investigator oversight and participants’ safety when physical examinations and face‐to‐face contact are limited. To facilitate future learning, hybrid clinical trials with both on‐site and decentralized elements are proposed by the respondents.