Technology & Support

Technology components

Digital tools in DCTs can improve real-world data collection, reduce participant travel, and offer more flexible engagement. However, there are challenges that come from integrating technology into trials: (1) reliance on cutting-edge yet immature technologies, (2) increased trial complexity, and (3) potential overload for clinical sites and participants.

Recommendations

A standardised framework for real-world data and common data models would enhance consistency and reliability. Prioritise interoperability by design in technology platforms to enable seamless integration and analysis of diverse data sources. Prioritise interoperability by design in technology platforms to enable seamless integration and analysis of diverse data sources. Conduct targeted technology scans specifically aligned with planned DCT activities to avoid overly broad or irrelevant outcomes.

Comprehensive pre-trial training should be provided for all stakeholders (site staff, home care teams, participants), focusing on practical technology use and a clear understanding of the trial processes.

Providing responsive, real-time technical assistance during the trial is essential to promptly resolve issues, minimize disruptions, and ensure data accuracy. This requires clearly defined communication channels to support continuous assistance, enabling swift escalation and resolution of complex problems. Maintaining short communication lines is critical—first-line support teams, including site staff and CRAs, should be equipped with the necessary technical knowledge to address issues immediately and report them effectively. Additionally, resources such as user guides and troubleshooting documentation should be readily accessible throughout the study to support timely problem-solving.

Ensure study teams recognise and anticipate common technical challenges (e.g., device setup, data errors), and are trained to offer basic troubleshooting guidance, reducing the impact of minor technical disruptions. Define an escalation process to respective study team members can promptly refer complex technical issues to specialists, minimising disruption. Include trial-specific technology training for respective study team members during pre-trial activities, enabling them to effectively assist and empower the primary stakeholders without themselves becoming technical experts.

It is important to maintain systematic oversight of third-party vendor activities, as this ensures reliability and compliance. First, define and apply predefined quality criteria (e.g., interoperability, usability, scalability) during procurement to select optimal technologies.

Throughout the trial, continuously track technology performance through proactive risk management strategies to promptly detect and mitigate potential issues. Develop mitigation plans (alternative workflows) for technologies that underperform and define contingency plans to ensure continuity of activities without compromising data quality, patient oversight, or participant experience. Monitor compliance with regulatory requirements and manage vendor performance effectively. Regularly conduct vendor audits to maintain consistent quality and ensure ongoing compliance.

When implementing a BYOD approach in DCTs, it is essential to define clear technical compatibility requirements—covering both software and hardware—for study applications and any connected devices interacting with participants’ personal smartphones. Early, geographically diverse field-testing using participant-sourced devices should be conducted to uncover potential regional or model-specific issues. To support effective troubleshooting, enable server-side logging and diagnostics to identify and resolve problems remotely. Study designs should incorporate fallback workflows, such as manual data entry options, that can be activated without initiating formal change requests. In cases where participant devices do not meet technical requirements, consider a hybrid provisioning model that provides study devices, while remaining mindful of the added burden posed by dual-device use. Finally, including a run-in phase to verify stable data flow before full enrolment can help ensure data integrity and reduce mid-study disruptions.

Allow sites hands-on access to the platform using test accounts and provide dummy hardware devices that replicate those used in the study. This helps site staff build familiarity with both the software and physical components, troubleshoot early, and reduce setup errors during actual participant onboarding.

When patient-facing technologies require independent home-based interaction, establish mandatory pre-enrollment testing phases incorporating simulated patient scenarios with comprehensive data collection and technology validation. This systematic approach enables site personnel to conduct end-to-end workflow rehearsals using test environments, facilitates early identification of technical vulnerabilities and operational bottlenecks, and ensures robust verification of system functionality and safety protocols prior to live participant engagement, thereby mitigating protocol deviation risks and maintaining study data integrity throughout the trial lifecycle.

How Trials@Home reached these recommendations

To aid in the selection of a technology package for RADIAL, we reviewed operational and technological approaches used in DCTs, then conducted an open call for DCT technologies. RADIAL served as a testbed for the implementation of this technology at scale. Rather than being based solely on theoretical frameworks, we have developed these recommendations from operational experiences. Valuable technology-related insights emerged from all major phases of the trial, from technology selection through to results-sharing.

Further reading

Publications

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials.

Rogers, et al
Trials
2021
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View poster version

Operationalising Decentralised Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial.

Hanke, et al
Clinical Pharmacology & Therapeutics
2025
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Deliverables

Detailed list of quality assessment criteria and assessment procedures

WP TECH,  2020
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Technology support system

WP TECH,  2023
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An interconnected, fully tested technology platform that connects the technological solutions chosen for the technology package and supports the WP3 pan-EU Pilot

WP TECH,  2023
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Updated summary and detailed report with recommendations for integrated technologies to be used in DCT and hybrid approaches, based on pilot findings

WP TECH,  2025
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Open call for additional technology partners

WP PROMS, 2021
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