Diffused responsibilities in technology-driven health research: The case of artificial intelligence systems in decentralized clinical trials

Sam H.A. Muller; Tessa I. van Rijssel; Ghislaine J.M.W. van Thiel

doi:10.1016/j.drudis.2025.104309

Diffused responsibilities in technology-driven health research: The case of artificial intelligence systems in decentralized clinical trials

Sam H.A. Muller
, Tessa I. van Rijssel^*
, Ghislaine J.M.W. van Thiel

^*Corresponding author for this work

University Medical Center Utrecht

Research output: Contribution to journal › Review article › peer-review

Abstract

Innovations such as artificial intelligence (AI) and decentralized clinical trials (DCTs) offer opportunities to enhance trial quality and efficiency. However, these innovations raise ethical questions about key responsibilities in research, such as participant safety and data quality. Using an example of an AI system determining personalized medication dosages in a DCT, we highlight how these technologies diffuse responsibilities among multiple actors and technologies. Diffusion diminishes the ability of actors to fulfill responsibilities. To address this, leading actors, such as sponsors, should prioritize overseeing responsibility attribution and implementation. This involves mapping responsibilities, identifying risks and challenges for fulfilling these responsibilities, and organizing adequate communication channels.

Original language	English
Article number	104309
Journal	Drug Discovery Today
Volume	30
Issue number	2
DOIs	https://doi.org/10.1016/j.drudis.2025.104309
Publication status	Published - Feb 2025
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2025 The Author(s)

Funding

TR and GT: The Trials@Home project has received funding from the Innovative Medicines Initiative (IMI; 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 program and European Federation of Pharmaceutical Industries and Associations (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 the IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein. SM and GT: The Hypermarker project was funded by the European Union under grant agreement number 101095480. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.

Funders	Funder number
European Federation of Pharmaceutical Industries and Associations
Horizon 2020 Framework Programme
European Commission	101095480
Innovative Medicines Initiative	831458

Keywords

artificial intelligence
decentralized clinical trials
digital health research
ethics
responsibility

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10.1016/j.drudis.2025.104309

Cite this

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abstract = "Innovations such as artificial intelligence (AI) and decentralized clinical trials (DCTs) offer opportunities to enhance trial quality and efficiency. However, these innovations raise ethical questions about key responsibilities in research, such as participant safety and data quality. Using an example of an AI system determining personalized medication dosages in a DCT, we highlight how these technologies diffuse responsibilities among multiple actors and technologies. Diffusion diminishes the ability of actors to fulfill responsibilities. To address this, leading actors, such as sponsors, should prioritize overseeing responsibility attribution and implementation. This involves mapping responsibilities, identifying risks and challenges for fulfilling these responsibilities, and organizing adequate communication channels.",

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AU - van Rijssel, Tessa I.

AU - van Thiel, Ghislaine J.M.W.

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AB - Innovations such as artificial intelligence (AI) and decentralized clinical trials (DCTs) offer opportunities to enhance trial quality and efficiency. However, these innovations raise ethical questions about key responsibilities in research, such as participant safety and data quality. Using an example of an AI system determining personalized medication dosages in a DCT, we highlight how these technologies diffuse responsibilities among multiple actors and technologies. Diffusion diminishes the ability of actors to fulfill responsibilities. To address this, leading actors, such as sponsors, should prioritize overseeing responsibility attribution and implementation. This involves mapping responsibilities, identifying risks and challenges for fulfilling these responsibilities, and organizing adequate communication channels.

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ER -

Diffused responsibilities in technology-driven health research: The case of artificial intelligence systems in decentralized clinical trials

Abstract

Bibliographical note

Funding

Keywords

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