Author: MRN
When the industry talks about Decentralized Clinical Trials (DCTs), it is often in a broad sense of the term and rarely with clear definitions and expectations outlined. As a result, confusion still lingers around what DCTs actually are and, more importantly, what they can achieve.
Looking to provide clarity on both, particularly in a European context, is the Trials@Home consortium – a partnership comprising of 35 international partners, including Medical Research Network (MRN). The consortium has spent six years researching DCTs in order to establish clear recommendations on how DCTs can be successfully designed and executed so that sponsors, sites and patients are empowered to take part in clinical research.
From Theory Into Practice
Trials@Home went beyond the conceptual, with the consortium carrying out a wide range of research activities – from stakeholder interviews and surveys to database studies, and even a proof-of-concept trial: the pan-European RADIAL trial.
The insights gathered over six-years of reviewing, analyzing and researching DCTs formed a robust foundation of recommendations that address the key elements of DCTs in detail, particularly patient engagement, site readiness, technology, and logistics.
Key Insights & Takeaways
One of the strongest takeaways is that early stakeholder engagement is essential. The path to successful implementation of DCTs starts long before recruitment, it begins in the design phase.
Researchers found that involving patient representatives, study staff, and other stakeholders early helps identify which activities make sense to decentralize, and which are best kept on-site. While some tests and procedures might be possible to do in the home to reduce travel time for a patient, they could introduce new challenges or make a patient uncomfortable – increasing site and patient burdens instead of alleviating them.
By engaging early and thinking carefully about each step, sponsors can design DCTs that are scientifically sound, operationally feasible, and genuinely patient-centric. Additionally, Trials@Home’s findings highlight that successful DCTs depend on supporting patients and sites and effectively leveraging technology.
Patients: Engagement and Support
Just as MRN’s Home Trial Support (HTS) solution has shown, placing patients at the heart of the trial design delivers the greatest value. Trials@Home did exactly that by establishing a patient panel who were involved in the trial from day one — helping shape study design and communication strategies. The key lessons?
- Clearly explain what’s expected of patients, from data collection to digital tools, so they can stay engaged and confident.
- Recognize that while many patients prefer remote participation, added burdens such as complex technology or unclear instructions can negatively impact their experience.
- Build responsive support systems, including user-friendly communication platforms, to keep patients connected and reassured throughout the process.
When patients feel supported and informed, they are more likely to enroll and stay engaged in a trial.
Clinical Sites: Training, Oversight, and Transparency
Sites remain central to trial success, what changes is the how and where they operate. Key recommendations from Trials@Home include providing sites with:
- Tailored training to fill digital skill gaps and support new technologies.
- Clear role definitions and oversight systems that ensure sites maintain visibility over data, even when third-party service providers are involved.
- Transparent contracting processes that recognize decentralized efforts and streamline trial start-up.
This approach echoes MRN’s work in supporting sites through their global Site Network and Site Support services — working with sites in communities and empowering them to utilize DCT elements as needed, without adding extra strain.
Technology: Governance, Testing, and Security
Technology is key to effective and efficient decentralization, but only when it’s implemented strategically and thoughtfully.
Strong data governance and privacy measures are critical – from Bring Your Own Device (BYOD) validation to GDPR compliance, every digital system must be secure, interoperable, and built with both patients and sites in mind.
Trials@Home also stresses the importance of selecting and testing tools early, ensuring smooth integration and reliability.
A Roadmap for the Future
By bringing together years of research and the real-world expertise of partners like MRN, the Trials@Home consortium has turned theory into practical guidance. The result is a set of clear, actionable recommendations that sponsors, CROs, and regulators can actually use. It’s a roadmap for how to make DCTs work in practice – grounded in collaboration, focused on what really happens in the field, and designed to make decentralized research simpler, smarter, and more sustainable.
These recommendations aren’t the endpoint; they’re the starting point. As DCTs continue to gain momentum, they will create a clearer path for sponsors, sites, and patients to take part in meaningful research that will make more life-saving therapies more accessible, faster.