Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

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.

SWOT analysis of decentralised clinical trials from an ethical, legal, regulatory and operational perspective — Murciano-Gamborino et al., BMC medical ethics · source ↗

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A critical assessment of recent decentralised trial experience, weighing what the model has delivered against what was claimed for it.

Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent Experiences — Wang et al., Clinical and Translational Science · source ↗

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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.

Recommendation Paper on Advancing the Use of Decentralised Elements in Clinical Trials — Bond et al., Therapeutic Innovation & Regulatory Science · source ↗

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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.

Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization — Gardarsdottir et al., Clinical pharmacology and therapeutics · source ↗

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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 status quo of the development of decentralized clinical trials — Chen et al., Frontiers in medicine · source ↗

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