Trials@Home Podcast Miniseries: Episode Four Overview
Decentralized and hybrid clinical trials continue to evolve as sponsors and research organizations seek more patient-centered, flexible approaches to study delivery. While these models offer clear advantages in terms of access and participation, concerns remain around operational complexity and perceived burden on clinical trial sites. This episode of the Trials at Home podcast miniseries explores how those concerns can be addressed in practice, drawing on operational insights and outcomes from the RADIAL proof-of-concept study.
The discussion centers on how decentralized trial elements, when designed and implemented thoughtfully, can reduce – rather than increase – site burden, while maintaining patient safety, data quality, and regulatory compliance.
Rethinking “Burden” in Decentralized Trial Models
Clinical trial burden is a longstanding challenge for sites, regardless of trial design. Administrative complexity, fragmented systems, and unclear responsibilities can lead to frustration and inefficiency. Decentralized clinical trials can amplify these challenges if processes are layered on without sufficient planning or support.
Key learnings from the RADIAL study underscore that burden is not inherent to decentralization itself. Instead, burden arises when roles, workflows, and communication pathways are poorly defined. Clear governance, fit-for-purpose training, and ongoing operational support are critical to ensuring decentralized elements enhance, rather than disrupt, site workflows.
Principal Investigator Oversight Beyond the Traditional Site
A central focus of the discussion is how principal investigator (PI) oversight is maintained when trial activities occur outside conventional clinical settings. Decentralized visits, including home-based assessments, do not change the PI’s responsibility for participant safety and trial conduct. However, they do require additional clarity around how oversight is exercised in practice.
Operational learnings highlight the importance of robust, study-specific documentation that clearly defines responsibilities between sites and third-party service providers, such as home nursing organizations. These documents go beyond standard delegation logs to outline specific activities, escalation pathways, and communication touchpoints. When oversight expectations are clearly articulated and supported by standardized templates, sites are better equipped to manage decentralized activities with confidence.
Site Readiness, Training, and Ongoing Support
Site experience and readiness vary widely across regions and organizations. One-size-fits-all training approaches are insufficient in decentralized and hybrid trials. The RADIAL study demonstrated that training must be tailored to site experience and delivered in a way that aligns with actual operational timelines.
“Just-in-time” training, delivered when sites are preparing to execute specific decentralized activities, proved more effective than front-loaded training delivered months in advance. Supplementing formal training with accessible support mechanisms, such as help desks and clear escalation routes, helped prevent minor issues from escalating into larger operational disruptions.
Equally important is simplifying communication. Sites benefit from having clear points of contact rather than navigating multiple vendors and systems. Streamlined communication structures reduce cognitive load and allow site teams to focus on patient care and trial delivery.
Shipments, Sample Collection, & Operational Clarity
Decentralized trials often involve direct-to-patient shipments, home-based sample collection, and coordination across multiple stakeholders. These activities introduce operational dependencies that must be carefully managed.
A recurring theme from RADIAL is the importance of explicit responsibility mapping. Defining who initiates shipments, who coordinates couriers, and how timelines are managed helps prevent delays that could impact visit completion or patient safety. Centralizing coordination, particularly by positioning home nursing teams as key operational hubs, was shown to improve reliability and reduce site workload.
Communication Timing and Risk-Based Planning
Effective communication between sites and decentralized service providers depends on timing as much as content. The episode emphasizes that referral processes and visit planning must allow sufficient lead time for preparation, particularly for complex home visits involving sample processing or specialized equipment.
Rather than applying fixed rules across all studies, communication plans should be risk-based and protocol-specific. Trials with frequent home visits may require early and ongoing coordination, while studies with limited decentralized activity can engage providers closer to execution. Documenting these timelines in advance helps align expectations and supports consistent execution across regions.
Informing Future Decentralized Trial Design
The operational insights discussed in this episode directly informed the final recommendations of the Trials at Home Consortium. Importantly, many of the most valuable learnings emerged from challenges encountered during implementation, reinforcing the value of real-world evidence in shaping best practices.
By applying these principles – clear oversight structures, tailored training, defined responsibilities, and risk-based planning – decentralized and hybrid trials can be designed to support sites, improve patient experience, and enable more sustainable global trial delivery.
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For more about the Trials@Home Consortium and to access their recommendations you can visit https://trialsathome.com/ or follow them on LinkedIn.