JMIR Publications

ABSTRACT

Background:

Decentralised Clinical Trials (DCTs) represent an emerging model in clinical research, leveraging digital technologies and local healthcare resources to increase accessibility and reduce the need for in-person visits. While various regulatory initiatives in Europe have sought to facilitate their implementation, the widespread adoption of DCTs remains limited due to significant operational, regulatory, and technological challenges.

Objective:

This study aimed to identify and prioritise actionable solutions to the main challenges of DCT implementation in Europe from a multi-stakeholder perspective.

Methods:

A two-round Delphi study was conducted involving 26 experts in clinical trials, ethics, law, regulation, and patient engagement between March and May 2023. In the first round, 244 unique proposals were collected and categorised according to six key challenges. In the second round, 39 synthesised proposals were evaluated using a Likert scale. Consensus was defined as ≥80% agreement on the appropriateness of each proposal.

Results:

High levels of consensus were achieved, with 82% of proposals rated as “appropriate” or “very appropriate”. Key recommendations included providing support and training for healthcare professionals, enhancing investigational medicinal product (IMP) and biological sample logistics through validated technologies, improving collaboration with local healthcare providers, fostering regulatory harmonisation while respecting national specificities, strengthening capacity-building initiatives, and promoting accessible, user-friendly digital tools supported by hybrid trial models.

Conclusions:

The study offers a consensus-based roadmap for overcoming the current barriers to DCT implementation in Europe. The adoption of these expert-driven solutions could support the development of more inclusive, efficient, and sustainable decentralised research frameworks across diverse healthcare systems. Clinical Trial: Not applicable