Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review

DSpace/Manakin Repository

Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review
 
Trials@Home Consortium
(2022) Drug Discovery Today, volume 27, issue 10, pp. 1 - 6
(Article)
Abstract
Decentralized clinical trials (DCTs) can be a valuable addition to the clinical trial landscape. However, the practice of DCTs is dependent on a regulatory system designed for conventional (site-based) trials. This study provides insight into the ethics review of DCTs. A 'mock ethics review' was performed in which members of ... read more
Download/Full Text
Open Access version via Utrecht University Repository Publisher version
Version on publisher website for UU-students and staff
Version on publisher website
 
Keywords: DCT, Decentralized clinical trials, Ethics committee, Ethics review, Research ethics, Drug Discovery, Pharmacology, Journal Article
DOI: https://doi.org/10.1016/j.drudis.2022.07.011
ISSN: 1359-6446
Publisher: Elsevier Limited
Note: Funding Information: We thank the focus group respondents for their contribution to this study. We thank Helga Gardarsdottir, Scott Askin, Solange Corriol-Rohou, and Johannes J.M. van Delden for their contributions in critically reviewing the manuscript. The Trials@Home project has received funding from the Innovative Medicines Initiative (www.imi.europa.eu) 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA. The research leading to these results was conducted as part of the Trials@Home consortium. This paper only reflects the personal view of the stated authors and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained here. Funding Information: We thank the focus group respondents for their contribution to this study. We thank Helga Gardarsdottir, Scott Askin, Solange Corriol-Rohou, and Johannes J.M. van Delden for their contributions in critically reviewing the manuscript. The Trials@Home project has received funding from the Innovative Medicines Initiative ( www.imi.europa.eu ) 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The research leading to these results was conducted as part of the Trials@Home consortium. This paper only reflects the personal view of the stated authors and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained here. Publisher Copyright: © 2022 The Authors
(Peer reviewed)