Need for greater post-trial support for clinical trial participants assessing high-risk, irreversible treatments

There are increasing numbers of clinical trials assessing high-risk, irreversible treatments. Trial participants should only expect knowledge gain to society, no personal therapeutic benefit. However, participation may lead to long-term harms and prevent future therapeutic options. While some discus...

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Bibliographic Details
Authors: Harris, Alex (Author) ; Gilbert, Frederic (Author)
Format: Electronic Article
Language:English
Check availability: HBZ Gateway
Interlibrary Loan:Interlibrary Loan for the Fachinformationsdienste (Specialized Information Services in Germany)
Published: 2025
In: Journal of medical ethics
Year: 2025, Volume: 51, Issue: 4, Pages: 268-273
Online Access: Volltext (lizenzpflichtig)
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Summary:There are increasing numbers of clinical trials assessing high-risk, irreversible treatments. Trial participants should only expect knowledge gain to society, no personal therapeutic benefit. However, participation may lead to long-term harms and prevent future therapeutic options. While some discussion has occurred around post-trial access to treatments for participants who received therapeutic benefit, there are no post-trial support requirements for those suffering long-term consequences from trial participation. Participants may be left with significant medical, psychological, social, technical or financial needs. All trials will end at some point, regardless of their success. Subsequently, they should be designed to take into account the post-trial period including the impact on the ongoing health of a participant and their post-trial needs.
ISSN:1473-4257
Contains:Enthalten in: Journal of medical ethics
Persistent identifiers:DOI: 10.1136/jme-2023-109719