Decentralised clinical trials: ethical opportunities and challenges.

Fuelled by adaptations to clinical trial implementation during the COVID-19 pandemic, decentralised clinical trials are burgeoning. Decentralised clinical trials involve many digital tools to facilitate research without physical contact between research teams and participants at various stages, such as recruitment, enrolment, informed consent, administering study interventions, obtaining patient-reported outcome measures, and safety monitoring. These tools can provide ways of ensuring participants' safety and research integrity, while sometimes reducing participant burden and trial cost. Research sponsors and investigators are interested in expanding the use of decentralised clinical trials. The US Food and Drug Administration and other regulators worldwide have issued guidance on how to implement such adaptations. However, there has been little focus on the distinct ethical challenges these trials pose. In this Health Policy report, which is informed by both traditional research ethics and digital ethics frameworks, we group the related ethical issues under three areas requiring increased ethical vigilance: participants' safety and rights, scientific validity, and ethics oversight. Our aim is to describe these issues, offer practical means of addressing them, and prompt the delineation of ethical standards for decentralised trials.

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Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests JS is a member of Merck KGaA's Ethics Advisory Panel and Stem Cell Research Oversight Committee, IQVIA's Ethics Advisory Panel, Aspen Neurosciences Clinical Advisory Panel, and Merck Data Monitoring Committee; and a consultant to Biogen. EV is a member of IQVIA's Ethics Advisory Panel and a member of Merck KGaA's Digital Ethics Advisory Panel. EV co-chaired the WHO expert group on Ethics and Governance for AI in Health. This work was supported by the Swiss National Science Foundation, NRP77 research grant number 407740_187356.