ICR discuss Decentralised Clinical Trials

The clinical research landscape is rapidly evolving, with decentralised clinical trials (DCTs) leading the way towards a more patient-centric, technology-driven future. As traditional methods blend with remote processes, understanding the foundations and implications of DCTs is crucial for researchers, sponsors, and healthcare professionals alike. Let’s explore five essential insights into DCTs that are shaping the future of clinical research.

The Future is Decentralised: Are You Ready?

Decentralised clinical trials are changing how we conduct research, making studies more accessible, efficient, and participant-friendly. Here’s what you need to know about this exciting evolution.

What Are Decentralised Clinical Trials (DCTs)?

Decentralised Clinical Trials, or DCTs, refer to studies where some or all trial activities are conducted remotely, away from traditional research sites. These activities might include virtual consultations, remote monitoring, home-based participation, or digital data collection. DCTs can range from fully remote trials to hybrid models that combine remote elements with onsite visits, offering unparalleled flexibility for participants and researchers.

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2. The Evolution of DCTs: A Rapid Transformation

Although decentralised elements have existed for years, the COVID-19 pandemic dramatically accelerated their adoption. Facing urgent needs to continue research safely, sponsors, providers, and regulators collaborated to establish emergency frameworks that supported remote trial activities. Today, DCTs are no longer temporary solutions but a permanent and growing aspect of clinical research, with formal guidelines from organisations like the HRA, EMA, and FDA backing their implementation.

3. Key Technologies Empowering DCTs

Technological advancements are at the heart of DCT success. Tools such as electronic consent (eConsent), telemedicine platforms, wearable devices, mobile apps for engagement, and remote monitoring systems allow researchers to maintain high standards of data integrity while enhancing participant convenience. However, accessibility considerations—especially for paediatric, elderly, or visually impaired populations—must be carefully addressed to ensure inclusivity across all trials.

4. Important Considerations When Designing a DCT

Not every study is suited for decentralisation. Factors like the type of investigational product, patient population, disease area, and technology access must be evaluated. Critical elements include ensuring product delivery and storage logistics, maintaining patient safety through robust oversight procedures, and managing data integrity through validated technology platforms. Clear protocol instructions, well-trained personnel, and contingency plans are essential to address the complexities of DCTs.

5. Navigating Regulatory Requirements

Regulators emphasise that patient safety, rights, dignity, and well-being must remain the top priorities in DCTs. Adherence to standards such as ICH E6, GDPR, and Good Clinical Practices (GCP) is non-negotiable. Fit-for-purpose technologies, rigorous vendor validation, secure data handling, and transparent documentation practices are critical for compliance. Collaboration with patient groups and healthcare professionals in trial design further enhances trial relevance and ethical conduct.

Join the ICR’s New DCT Special Interest Group (SIG)

The ICR DCT SIG is now formally launched! This Special Interest Group is being led by Stacey Fergusson and Graham Wylie and supported by an enthusiastic, thought-leading organising committee:

  • Janet Messer
  • Katharine Hatton
  • Jo Gambell
  • Davina Calbraith
  • Magda Laskawiec-Szkonter

The team recently held a productive kick-off meeting, and exciting plans are already underway. The first online event will take place in Q2 2025 and will provide a deep dive into the challenges, successes, and lessons learned from the practical implementation of a decentralised clinical trial. More details will be announced soon. In addition, the group is planning further events for 2025, including both online and in-person forums and regional meetings, to explore key topics shaping the future of DCTs.

If you have suggestions for event themes or DCT-related topics, please share them with Stacey Fergusson for inclusion in future SIG planning. We look forward to engaging with you at an upcoming event!

ICR- Embracing the Future of Clinical Trials

Decentralised clinical trials represent a transformative shift in clinical research, offering exciting opportunities to make trials more accessible, efficient, and patient-friendly.

Ready to deepen your understanding of decentralised clinical trials? Join the ICR’s DCT Special Interest Group, subscribe to our newsletter, or attend one of our upcoming webinars. Stay at the forefront of innovation in clinical research with the Institute of Clinical Research (ICR) – visit ICR Global today!

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