2025 · Clinical pharmacology and therapeutics · open access
The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants-Insights from the Trials@Home RADIAL Proof-of-Concept Trial
Heath et al.
The finding, in our words
The RADIAL proof-of-concept trial delivered investigational medicinal products directly to participants with a 94 percent success rate across six European countries, though drop-off of biological samples was more challenging in the fully remote arm. Key obstacles included regulatory divergence, unclear vendor responsibilities, and unreliable sample collection, showing that decentralised trials need robust logistics, temperature control, and participant training to ensure safety and data integrity.
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