Decentralized clinical trials (DCTs) have evolved the research landscape by bringing studies directly to patients, enhancing accessibility, and reducing the burden of participation. However, while DCTs offer significant benefits, they also introduce new complexities that sponsors, CROs, and sites must navigate to ensure trial success.
In this article, we explore the most common challenges in decentralized trials and offer practical advice and industry-tested strategies – along with how mdgroup’s patient-centric services support their resolution.
1. Maintaining Patient Engagement and Retention
The challenge: Without regular face-to-face contact at a central site, it can be harder to maintain a strong connection with participants. This can lead to decreased engagement, poor compliance, and higher dropout rates.
How to overcome it: Building a robust patient engagement strategy is key. This includes regular communication, providing educational resources in plain language, and incorporating feedback loops to understand and respond to patient needs. Assigning a consistent point of contact also fosters trust and continuity.
mdgroup enhances this through its navigator service, which ensures every participant has a dedicated liaison. Combined with regular check-ins and updates via our primarius platform, this approach supports strong retention and engagement throughout the trial.
2. Logistical Complexities
The challenge: Coordinating home visits, shipping investigational products (IMP), and managing sample collection and transport across regions can be operationally demanding.
How to overcome it: Successful logistics in DCTs require clear planning, regional expertise, and a strong supply chain infrastructure. Sponsors should ensure vendors can manage everything from cold chain transport to regulatory requirements across multiple geographies.
Our ondemand and mobilehealth services support this with compliant travel, home healthcare, and efficient sample and equipment distribution via horreum, our global network of medical distribution centres. Real-time logistics tracking through primarius adds an extra layer of reliability and transparency.
3. Data Collection and Consistency
The challenge: Collecting high-quality, consistent data from patients in different locations can be more complex in decentralized trials, especially when relying on remote devices or multiple vendors.
How to overcome it: Use standardised protocols and provide clear instructions for patients and healthcare providers involved in remote data collection. Employ centralised platforms for data capture and monitoring to ensure uniformity and timely reporting.
mdgroup supports this with our primarius platform, which integrates digital tools like eConsent and wearable monitoring. Our mobilehealth professionals follow strict, protocol-driven procedures to maintain consistency across patient assessments.
4. Regulatory and Compliance Hurdles
The challenge: Decentralized clinical trials often span multiple regions, making it challenging to comply with diverse regulatory requirements for telemedicine, data privacy, and IMP handling.
How to overcome it: Stay up to date with international guidelines, including those from the FDA, EMA, and local regulatory bodies. Collaborate with experienced partners who understand regional differences and can provide operational guidance.
European regulators have weighed in on the decentralised trial model, outlining both its opportunities and challenges. Read their full perspective in this publication.
At mdgroup, our workflows are designed with compliance at their core. We adapt our SOPs to meet country-specific regulations and ensure data privacy through strict adherence to GDPR, HIPAA, and other relevant standards.
5. Technology Adoption and Patient Digital Literacy
The challenge: Not all patients are equally comfortable with digital tools, which can limit participation and affect the user experience.
How to overcome it: Simplify technology interfaces and offer onboarding and training for patients. Maintain a balance between digital and human interaction by providing multiple support channels and ensuring tools are accessible to users of varying tech literacy levels.
Through our navigator service, mdgroup offers comprehensive patient onboarding and ongoing tech support. The primarius patient app is designed for ease of use, with 24/7 help available via phone, email, or chat, ensuring no participant is left behind.
Conclusion
Decentralized clinical trials represent the future of research—but they require careful planning, smart technology, and a deeply patient-centric approach to overcome their challenges.
By applying industry best practices—like simplifying protocols, maintaining strong communication, and ensuring accessibility—sponsors and CROs can unlock the full potential of DCTs.
At mdgroup, we provide the infrastructure, expertise, and compassionate care needed to make decentralized and hybrid trials successful. Our suite of services, underpinned by the primarius platform, ensures that every patient experience is seamless, supportive, and compliant.
Want to make your clinical trial more efficient and accessible? Contact us to learn how mdgroup can support your next decentralized study.
