2025 · Clinical pharmacology and therapeutics · open access
Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial
Malhotra et al.
The finding, in our words
In a Phase 1 crossover study of etrasimod, self-collected blood microsamples yielded pharmacokinetic exposures comparable to conventional venous sampling, both with and without participant practice sessions. Continuous wearable sensors concurrently enabled real-time remote monitoring of safety vital signs and electrocardiograms, demonstrating the viability of hybrid decentralised designs in early-phase clinical trials.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
In this decentralised n-of-1 crossover trial of dapagliflozin in 20 adults with type 2 diabetes, remote collection of urine and capillary blood samples achieved 99.4% and 98.4% delivery success respectively, demonstrating that remote monitoring can reliably track individual albuminuria responses to therapy.
The study found that smartwatch-based adherence monitoring showed consistent concordance over time and may be more reliable than app or pill count methods in measuring treatment adherence in a decentralised setting. This supports the use of wearable devices as objective tools in patient-centric monitoring for decentralised clinical trials.
Huh et al., Clinical and translational science · source ↗
Decentralised monitoring of people with type 2 diabetes using continuous glucose monitoring and a hybrid smartwatch was feasible, with high participant retention and successful collection of glucose, heart rate, activity, sleep and GPS data via a study app.
Ali et al., Journal of diabetes science and technology (paywalled) · source ↗
This proof-of-concept study demonstrated that patients with inflammatory bowel disease could successfully perform capillary blood microsampling at home with high analytical success rates, and a majority preferred this decentralised approach over hospital venous draws.
Schuurman et al., Inflammatory bowel diseases · 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.