TY - JOUR
T1 - Opportunities and Challenges for Decentralized Clinical Trials
T2 - European Regulators' Perspective
AU - de Jong, Amos J
AU - van Rijssel, Tessa I
AU - Zuidgeest, Mira G P
AU - van Thiel, Ghislaine J M W
AU - Askin, Scott
AU - Fons-Martínez, Jaime
AU - De Smedt, Tim
AU - de Boer, Anthonius
AU - Santa-Ana-Tellez, Yared
AU - Gardarsdottir, Helga
N1 - Funding Information:
This work has received support from the EU/EFPA Innovative Medicines Initiative Joint Undertaking Trials@Home (grant No. 831458). The Innovative Medicines Initiative (IMI) website can be accessed through the following link: www.imi.europa.eu .
Funding Information:
This work has received support from the EU/EFPA Innovative Medicines Initiative Joint Undertaking Trials@Home (grant No. 831458). The Innovative Medicines Initiative (IMI) website can be accessed through the following link: www.imi.europa.eu. The authors thank the respondents for their time and willingness to participate in this research project.
Publisher Copyright:
© 2022 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
PY - 2022/8
Y1 - 2022/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85131516876&partnerID=8YFLogxK
U2 - 10.1002/cpt.2628
DO - 10.1002/cpt.2628
M3 - Article
C2 - 35488483
SN - 0009-9236
VL - 112
SP - 344
EP - 352
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
IS - 2
ER -