Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home <scp>RADIAL</scp> Proof‐of‐Concept Trial

While decentralized clinical trials (DCTs) hold great promise for improving trial accessibility and efficiency, the effective deployment of DCT elements requires robust technological infrastructure and careful system integration. Although several innovative technologies are now available for implementing DCT elements, most existing setups integrate single-vendor solutions, which restrict the potential for tailored trial designs as well as seamless interoperability between different platforms and solutions. This paper presents operational learnings from the Trials@Home RADIAL proof-of-concept trial. RADIAL implemented a modular, multi-vendor technology package. RADIAL adopted a deliberate strategy to avoid a monolithic "one-vendor-for-all" solution, instead selecting technologies and integrating them only where it added clear value. Core systems-such as eConsent and Bluetooth glucometer-were fully integrated into the central platform, while other components were deliberately managed outside the core system. The aim was to implement and validate a multi-vendor technology setup and generate learnings that would help DCT trialist in designing DCTs, especially in terms of technology selection and integration. Key challenges arose from Bring Your Own Device (BYOD) variability, immature device technologies, and infrastructure limitations at clinical sites-particularly affecting components like telemedicine. The results emphasize the significance of investing in participant support infrastructure, as well as early cross-functional support, while automated, multichannel notifications seem to guide participant engagement. Finally, embedding compliance by planning early streamlines documentation through a clear governance model seemed to enhance agility and reduce burden.

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Publication Details

Journal
Clinical Pharmacology & Therapeutics
Published
2025-09-19
DOI
https://doi.org/10.1002/cpt.70070
Citations
4
Primary Topic
Mobile Health and mHealth Applications
Type
article
Field-Weighted Citation Impact
11.26

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article

Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof‐of‐Concept Trial

Brian M. Guthrie, Lampros Mpaltadoros, Bernhard Neumayer, Sten Hanke et al.
4 citations
Clinical Pharmacology & Therapeutics
Mobile Health and mHealth Applications
11.26
article

Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof‐of‐Concept Trial

Brian M. Guthrie, Lampros Mpaltadoros, Bernhard Neumayer, Sten Hanke, Bart Lagerwaard, Mira G. P. Zuidgeest, Dimitrios Giannikopoulos, Richard T. Davey, Rebecca Jackson, Tea Vedenkannas
article en
4 citations

Abstract

While decentralized clinical trials (DCTs) hold great promise for improving trial accessibility and efficiency, the effective deployment of DCT elements requires robust technological infrastructure and careful system integration. Although several innovative technologies are now available for implementing DCT elements, most existing setups integrate single-vendor solutions, which restrict the potential for tailored trial designs as well as seamless interoperability between different platforms and solutions. This paper presents operational learnings from the Trials@Home RADIAL proof-of-concept trial. RADIAL implemented a modular, multi-vendor technology package. RADIAL adopted a deliberate strategy to avoid a monolithic "one-vendor-for-all" solution, instead selecting technologies and integrating them only where it added clear value. Core systems-such as eConsent and Bluetooth glucometer-were fully integrated into the central platform, while other components were deliberately managed outside the core system. The aim was to implement and validate a multi-vendor technology setup and generate learnings that would help DCT trialist in designing DCTs, especially in terms of technology selection and integration. Key challenges arose from Bring Your Own Device (BYOD) variability, immature device technologies, and infrastructure limitations at clinical sites-particularly affecting components like telemedicine. The results emphasize the significance of investing in participant support infrastructure, as well as early cross-functional support, while automated, multichannel notifications seem to guide participant engagement. Finally, embedding compliance by planning early streamlines documentation through a clear governance model seemed to enhance agility and reduce burden.

Clinical Pharmacology & TherapeuticsVol. 118(5)
FH JOANNEUM University of Applied Sciences (AT), Johnson & Johnson (United States) (US), University Medical Center Utrecht (NL), Information Technologies Institute (GR), Janssen (United Kingdom) (GB), Cambridge Cognition (United Kingdom) (GB), Centre for Research and Technology Hellas (GR), Johnson & Johnson (United Kingdom) (GB), Bayer (Finland) (FI), United States Army Research Office (US), Bayer (Germany) (DE)
European Federation of Pharmaceutical Industries and Associations, European Commission
Openalex Percentile: Top 2%
Mobile Health and mHealth Applications
11.26
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