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.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
The study found that although participants preferred patient-centric microsampling devices for home use, the agreement with venous plasma for measuring CRP and cytokines was inconsistent, indicating that further validation is required before these methods replace standard venipuncture.
A machine learning model called Remote Control was trained on 2685 blood samples to predict change due to instability, enabling accurate calibration of results to approximate the time zero value at collection. With calibration, unprocessed whole blood could be transported for up to 9 days under ambient conditions and temperatures between 3.4 and 47.4 degrees Celsius, achieving agreement with CLIA TEa between 98.1 and 100 per cent and expanding the catalog of tests available for at-home collection.
O'Meara et al., Analytical chemistry (paywalled) · source ↗
This study found strong concordance between capillary samples collected via the Tasso device and standard venous draws for VirScan serology, indicating that self-collected samples are a practical alternative for decentralised research. The authors advise against interchanging these collection methods within a single longitudinal study to avoid introducing technical variability.
In a pilot mixed-methods study of youth with HIV, mailed HemaSpot-HF kits enabled home-based dried blood spot collection that participants found feasible and acceptable, supporting remote viral load monitoring and a self-management model for decentralised care.
Gurung et al., AIDS and behavior (paywalled) · source ↗
This developer study reports that a self-collection kit interfacing with a BD Microtainer produced RNA of sufficient quality and yield for transcriptomic analysis in a pilot group and a longitudinal rheumatology cohort. Most participants found the device easy to use, supporting its utility for decentralised blood sampling.
Eakman et al., Analytical chemistry (paywalled) · source ↗