Decentralised clinical trials: ethical opportunities and challenges
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Author / Producer
Date
2023-06
Publication Type
Journal Article
ETH Bibliography
yes
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Abstract
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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published
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Book title
Journal / series
Volume
5 (6)
Pages / Article No.
Publisher
Elsevier
Event
Edition / version
Methods
Software
Geographic location
Date collected
Date created
Subject
Organisational unit
09614 - Vayena, Eftychia / Vayena, Eftychia
Notes
Funding
187356 - Digital Health Innovation: a Governance Roadmap for Switzerland (D-GOVmap) (SNF)