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

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.

Figure 1

Overview of RADIAL’s hub‐and‐spoke technology architecture. EDC, Electronic Data Capture; ePRO, electronic Patient‐Reported Outcome; eConsent, electronic Consent; eDiary, electronic Diary; RTSM, Randomization and Trial Supply Management.

Figure 2

Integration of the insulin treatment adherence system.