ArticleClinical pharmacology and therapeutics2025
The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants-Insights from the Trials@Home RADIAL Proof-of-Concept Trial.
Article in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial.Clinical pharmacology and therapeutics · 2025Article
- Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization.Clinical pharmacology and therapeutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Decentralized clinical trials (DCTs), which move trial activities to participants' homes or direct surroundings, offer potential advantages over conventional site-based trials through reduced participant burden and improved accessibility. The direct-to-participant (DtP) delivery of investigational medicinal products (IMPs) and other study materials and collection of biological samples requires careful planning and execution to ensure participant safety and data integrity. Here, we report operational experiences from the RADIAL proof-of-concept trial, a three-arm parallel-group study conducted across six European countries comparing conventional, hybrid, and fully decentralized approaches in type 2 diabetes patients. The study implemented two DtP IMP models: clinical trial site-to-participant and central pharmacy-to-participant delivery, with comprehensive logistics tracking and temperature monitoring. In RADIAL, 68 DtP IMP shipments were executed with a 94% successful delivery rate. Four shipments (6%) failed due to participant unavailability, temperature excursions, defective monitoring equipment, or courier loss. The central pharmacy model demonstrated inventory savings compared with conventional site-based distribution. Biological sample collection for HbA1c assessment was done through drop-off, which proved more challenging in the remote arm. Key challenges related to DCT logistics as experienced in RADIAL included unclear importer/exporter responsibilities, regulatory divergence across countries, participant material management, and sample drop-off reliability. DtP IMP delivery and biological sample collection are feasible in European DCTs but require enhanced planning, clear vendor responsibilities, and robust contingency procedures. Success depends on appropriate participant training, reliable courier services, temperature control systems, and accessible biological sample collection methods.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.