Trials@Home Podcast Miniseries: Episode Two Overview
As decentralized clinical trials (DCTs) continue to reshape clinical research, one question remains central: how can sponsors, sites, and service providers ensure these models are scientifically robust, operationally sound, and acceptable to all stakeholders involved?
This question sat at the heart of the Trials@Home Consortium’s work—and more specifically, the RADIAL trial, a pilot study designed to move the conversation around decentralization from theory into practice.
Why the RADIAL Trial Mattered
While early DCT adoption relied heavily on retrospective case studies and isolated implementations, the Trials@Home Consortium recognized the need for contemporary, comparative data. The RADIAL trial was designed as a proof-of-concept study to directly evaluate decentralized, hybrid, and traditional site-based trial models within a single protocol.
Conducted as a Phase IV, multi-center study across six European countries, RADIAL focused on a well-characterized Type 2 diabetes population. This deliberate choice ensured that safety and efficacy were well understood, allowing the study to concentrate on what truly differentiates decentralized trials: operational quality, data integrity, participant experience, and stakeholder acceptability.
By comparing a conventional site-based arm, a hybrid arm combining telehealth and home visits, and a fully remote arm, the RADIAL trial generated real-world evidence on how different trial designs perform when placed under the same scientific lens.
From Pilot Study to Practical Recommendations
The RADIAL trial did not exist in isolation. It complemented nearly six years of broader research conducted by the Trials@Home Consortium, ultimately informing nine core recommendations for decentralized trial design and execution.
These recommendations emphasize the importance of early stakeholder engagement, clear communication with participants, thoughtful selection of decentralized activities, and proactive regulatory and ethical planning. Just as critically, they highlight operational realities—such as logistics, technology readiness, role clarity, and data privacy—that can determine whether a DCT succeeds or stalls.
One of the most consistent findings from RADIAL was that decentralization is not simply about replacing site visits with remote alternatives. Instead, it requires intentional coordination, particularly when care delivery shifts into the patient’s home.
Where In-Home Trial Support Makes the Difference
This is where experienced in-home trial providers play a pivotal role. The RADIAL trial reinforced that placing trained research nurses at the center of decentralized models improves coordination between sponsors, sites, patients, and third-party vendors. When oversight, communication, and logistics are centralized, trials operate more efficiently—and patient safety is never compromised.
Equally important is maintaining principal investigator oversight in remote or hybrid trials. Robust documentation, transparent delegation processes, and clear data flows ensure investigators remain fully informed, even when patients never physically visit a site.
These are not theoretical challenges. Contracting delays, medication distribution issues, and fragmented data collection remain some of the most common obstacles in decentralized trials. Addressing them early—during protocol design rather than trial execution—can significantly reduce delays and downstream risk.
Moving DCTs Forward with Confidence
The RADIAL trial demonstrated that decentralized and hybrid trials can meet the same scientific and operational standards as traditional models—when implemented correctly. For sponsors and sites considering decentralized approaches, the message is clear: success depends less on innovation alone and more on experience, planning, and execution.
As decentralized clinical trials continue to evolve, evidence-based frameworks like Trials@Home—and proven in-home trial support models—will remain essential to translating promise into performance.
Follow MRN on LinkedIn for more updates and podcasts about our involvement in the Trials@Home Consortium.
For more about the Trials@Home Consortium and to access their recommendations you can visit https://trialsathome.com/ or follow them on LinkedIn.