2026 · Journal of medical Internet research · open access
Addressing the Key Challenges of Decentralized Clinical Trials in Europe: Multistakeholder Perspective Delphi Study
Murciano-Gamborino et al.
The finding, in our words
Experts achieved high consensus on recommendations to support decentralised clinical trials in Europe, including training for health care professionals, improving biological sample logistics, and fostering regulatory harmonization. These prioritized solutions aim to overcome barriers to adoption and create more inclusive and efficient research frameworks.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The Australian Teletrial Programme improved patient access to trials and workforce capability through harmonised processes and training, but broader implementation is limited by workforce turnover, complex approvals, and variable leadership engagement. This highlights that systemic policy and governance support are critical for the sustainable integration of decentralised trial models.
Sabesan et al., Journal of telemedicine and telecare (paywalled) · source ↗
The study identified 48 strengths, 62 weaknesses, 5 opportunities, and 13 threats across eight key trial activities in decentralised clinical trials, highlighting potential advantages like remote participation and challenges such as digital technology barriers and privacy issues.
Murciano-Gamborino et al., BMC medical ethics · source ↗
A recommendation paper on extending decentralised elements in trials, covering the conditions under which trial activity, including biological sample collection, may take place away from the investigator site.
Bond et al., Therapeutic Innovation & Regulatory Science · source ↗
The Trials@Home RADIAL trial's regulatory record across six European countries: early and continuous engagement with regulators made the decentralised elements possible, and harmonised guidance is still needed where national legislation differs.
Gardarsdottir et al., Clinical pharmacology and therapeutics · source ↗