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

Trials@Home Consortium

doi:10.1016/j.drudis.2022.07.011

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

Trials@Home Consortium

Research output: Contribution to journal › Article › Academic › peer-review

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 European ethics committees (ECs) and national competent authorities (NCAs) discussed and reviewed a DCT protocol. Respondents expressed hesitancy toward DCTs and focused on potential risks and burdens. We advise to address these aspects explicitly when submitting a DCT protocol. We propose that both the benefits and risks of DCTs should be carefully monitored to advance the review and practice of this innovative approach to ethically optimize drug development.

Original language	English
Article number	103326
Pages (from-to)	1-6
Journal	Drug Discovery Today
Volume	27
Issue number	10
DOIs	https://doi.org/10.1016/j.drudis.2022.07.011
Publication status	Published - Oct 2022

Bibliographical 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

Keywords

DCT
Decentralized clinical trials
Ethics committee
Ethics review
Research ethics

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1-s2.0-S1359644622002963-mainFinal published version, 211 KBLicence: CC BY

Cite this

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title = "Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review.",

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 European ethics committees (ECs) and national competent authorities (NCAs) discussed and reviewed a DCT protocol. Respondents expressed hesitancy toward DCTs and focused on potential risks and burdens. We advise to address these aspects explicitly when submitting a DCT protocol. We propose that both the benefits and risks of DCTs should be carefully monitored to advance the review and practice of this innovative approach to ethically optimize drug development.",

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author = "{Trials@Home Consortium} and {van Rijssel}, {Tessa I} and {de Jong}, Amos and Yared Santa-Ana-Tellez and Martin Boeckhout and M.G.P. Zuidgeest and {van Thiel}, {Ghislaine J. M. W.}",

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{\textquoteright}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: {\textcopyright} 2022 The Authors",

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

Abstract

Bibliographical note

Keywords

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