Abstract
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.
Original language | English |
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Pages (from-to) | 344-352 |
Number of pages | 9 |
Journal | Clinical Pharmacology and Therapeutics |
Volume | 112 |
Issue number | 2 |
Early online date | 30 Apr 2022 |
DOIs | |
Publication status | Published - Aug 2022 |
Bibliographical note
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.
Keywords
- Humans
- Research Personnel