Trials@Home Podcast Miniseries: Episode Three Overview
Decentralized clinical trials continue to evolve as sponsors, sites, and research partners explore new ways to increase access, flexibility, and efficiency in clinical research. This episode of the Trials at Home podcast miniseries examines how decentralized clinical trial (DCT) recommendations were applied in practice through the RADIAL proof-of-concept study, with a focus on operational outcomes and implementation learnings.
RADIAL Study Design & Trial Delivery Models
The RADIAL study was designed to evaluate how different levels of decentralization impact trial conduct, participant experience, and site operations. The study compared three trial delivery models:
- A conventional site-based model
- A hybrid model combining site visits with remote and in-home procedures
- A fully remote model with no direct physical interaction between participants and site staff
This structure enabled comparison across varying degrees of decentralization and provided insight into how decentralized approaches perform under different operational conditions. By evaluating these models side by side, the study aimed to identify where decentralized methods add value and where they introduce additional complexity.
Decentralized Clinical Trial Elements Evaluated
To ensure the findings were broadly applicable, the RADIAL study incorporated a wide range of decentralized clinical trial components, including:
- Online recruitment and remote pre-screening
- Remote informed consent, using digital consent tools where permitted
- Telemedicine-based study visits to support ongoing communication
- Direct-to-patient delivery of investigational medicinal product (IMP) and study materials
- Wearable devices and sensor-based data collection
- Use of a dedicated study mobile application
- Home nursing visits for sample collection and participant support
These elements were implemented across different trial arms and geographies, reflecting variations in regulatory frameworks, infrastructure, and operational requirements.
Participant Experience & Satisfaction Outcomes
Participant satisfaction was a key performance indicator assessed throughout the study. Feedback was collected at multiple time points using a questionnaire adapted to capture experiences specific to decentralized and hybrid trial participation.
Results demonstrated that satisfaction varied across trial arms and over time. While decentralized approaches were intended to increase convenience and flexibility, technology-related challenges influenced participant experience. These included mobile application usability issues, device compatibility limitations, and varying levels of digital literacy. Such challenges were more prominent in the fully remote trial arm.
In contrast, decentralized components that involved direct human interaction—such as home nursing visits and telemedicine consultations—were associated with consistently positive feedback. These findings highlight the importance of maintaining human touchpoints within decentralized and hybrid trial models to support participant understanding, confidence, and ongoing engagement.
Site Experience & Operational Considerations
Site satisfaction was evaluated at multiple milestones, from site activation through last patient last visit. Overall, site satisfaction declined during the course of the study, with technology burden identified as a primary contributing factor.
Sites reported challenges related to integrating new digital tools into existing workflows and managing operational issues when systems did not function as expected. Feedback indicated that site experience with decentralized methodologies varied widely, and that a standardized approach to training and support was not sufficient to meet all site needs.
These findings reinforce the importance of maintaining a site-centered perspective alongside patient-centered trial design. Effective decentralized trials require early engagement, clear communication, and tailored support models that reflect site capabilities and experience.
Key Learnings & Consortium Recommendations
Operational insights from the RADIAL study directly informed the final recommendations developed by the Trials at Home Consortium. The study demonstrated that decentralized clinical trials can expand reach and flexibility, but only when implemented with realistic expectations, appropriate resourcing, and sustained human support.
Key learnings included:
- Digital tools alone do not ensure successful decentralization
- Human-led elements remain critical to participant and site satisfaction
- Tailored training and support improve adoption and execution
- Flexible operational models are required to accommodate diverse environments
For organizations planning decentralized or hybrid clinical trials, the RADIAL experience provides practical insight into how decentralized elements function in real operational settings and the support structures required to enable successful implementation across regions.
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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.