2025 · Contemporary clinical trials communications · open access
Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals
Ye et al.
The finding, in our words
In a decentralised phase 1 trial, healthy adults used a clinical trial app to self-collect blood microsamples and vital signs at home, with 65 to 70 per cent successfully providing blood samples and most preferring self-collection over staff collection.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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 ↗
In a 20-person proof-of-concept pilot among veterans with HIV, remote self-collection of dried blood spots for phosphatidylethanol monitoring was feasible and acceptable, with high return and analysis rates and positive feedback; a small first step toward decentralised alcohol biomarker monitoring rather than proof of it.
Sheinfil et al., Journal of substance use and addiction treatment (paywalled) · source ↗
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.
Malhotra et al., Clinical pharmacology and therapeutics · source ↗
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.
Thirty-eight patients with rheumatic diseases showed high engagement with twice-daily smartphone symptom reporting (95% completion) and remote dried blood spot collection (84% returned samples, all viable for C-reactive protein analysis). Although symptoms varied considerably, clinically meaningful CRP changes were rare, confirming the feasibility of integrating microsampling with patient-generated health data in decentralised rheumatology research.
Druce et al., BMC musculoskeletal disorders · source ↗