Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals

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.

Implementation of a Capillary Blood Self-Sampling Technique at Home for Monitoring of Patients With IBD — Schuurman et al., Inflammatory bowel diseases · source ↗

• acceptability
• multimodal
• blood
• rpm
• self-collection
• capillary
• liquid

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.

Remote alcohol biomarker monitoring to promote drinking reductions among people with HIV: A proof-of-concept pilot study — Sheinfil et al., Journal of substance use and addiction treatment (paywalled) · source ↗

• acceptability
• multimodal
• blood
• rpm
• dbs
• self-collection
• dried
• biomarkers

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.

Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial — Malhotra et al., Clinical pharmacology and therapeutics · source ↗

• blood
• capillary
• self-collection
• venous-agreement
• dct
• wearable
• rpm
• digital-biomarker
• multimodal

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.

Albuminuria Responses to Dapagliflozin in Patients With Type 2 Diabetes: A Crossover Trial — Beernink et al., JAMA network open · source ↗

• dct
• multimodal
• blood
• rpm
• self-collection
• capillary
• urine
• biomarkers

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.

Remote sampling of biomarkers of inflammation with linked patient generated health data in patients with rheumatic and musculoskeletal diseases: an Ecological Momentary Assessment feasibility study — Druce et al., BMC musculoskeletal disorders · source ↗

• blood
• dried
• dbs
• self-collection
• acceptability
• biomarkers
• rpm
• digital-biomarker
• multimodal