2025 · Therapeutic Innovation & Regulatory Science · open access
Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials
Bond et al.
The finding, in our words
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.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
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.
This literature review maps the regulatory landscape for decentralised clinical trials across the US, EU and China, finding that the US emphasises efficiency and technological integration, the EU prioritises equity and patient engagement, and China focuses on rare diseases with a cautious regulatory approach. It argues that fragmented governance across jurisdictions hampers the full realisation of DCTs and calls for greater international harmonisation.
The authors outline that FDA supports decentralised clinical trials to boost participation, noting that while they offer convenience for participants, successful implementation requires careful coordination, remote supervision, training, and risk management. This matters because it establishes the regulatory context and operational considerations for deploying patient-centric microsampling and remote monitoring in drug development.