2025 · Clinical pharmacology and therapeutics · open access
Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization
Gardarsdottir et al.
The finding, in our words
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.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
A 2025 review maps 28 microsampling devices, from dried spots and volumetric absorptive tips to upper-arm liquid capillary collectors, and names what a laboratory must control before their results are used: the haematocrit effect in non-volumetric dried samples, interstitial fluid from finger milking, volume, haemolysis and transport stability. Regulators on both sides of the Atlantic ask for the same two things, a device the patient can use safely and a sample fit for the test.
This workshop report provides recommendations on blood sampling sites, bridging study design, and statistical methods for correlation to support the adoption of microsampling in patient-centric drug development. It emphasises the critical need for away-from-clinic sampling techniques to maintain patient safety during the COVID-19 pandemic.
Guidance on capillary-to-plasma conversion: method- and analyte-specific clinical validation with paired capillary–venous samples before reporting plasma-equivalent results.
Boffel et al., Therapeutic Drug Monitoring (paywalled) · source ↗
In four crew members, capillary volumetric absorptive microsampling caught altered acetaminophen pharmacokinetics in flight: Cmax rose to 43,300 ng/mL from 9,110 before flight and clearance fell to 3,890 mL/h from 16,200, pointing to toxicity risk at standard dosing; four people only, but a case for microsampling where no clinic can reach.
Mampre et al., Journal of clinical pharmacology · source ↗
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 ↗