Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm

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

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.

Exploring Decentralized Glucose and Behaviometric Monitoring of Persons with Type 2 Diabetes in the Setting of a Clinical Trial — Ali et al., Journal of diabetes science and technology (paywalled) · source ↗

• dct
• actigraphy
• wearable
• multimodal
• cgm
• rpm
• self-collection
• digital-biomarker
• interstitial-fluid

The study found that although participants preferred patient-centric microsampling devices for home use, the agreement with venous plasma for measuring CRP and cytokines was inconsistent, indicating that further validation is required before these methods replace standard venipuncture.

Limited agreement of cytokines and CRP through patient-centric microsampling compared to venipuncture in healthy adults — Tuttle et al., Bioanalysis (paywalled) · source ↗

• dct
• venous-agreement
• acceptability
• blood
• dbs
• self-collection
• dried
• biomarkers

The study demonstrated the feasibility of a fully decentralised design by successfully recruiting 37 participants and completing follow-up for self-collected stool samples without requiring on-site visits.

Perioperative Antibiotic Prophylaxis in Cesarean Section and the Maternal Gut Microbiome: Protocol for a Remote Observational Cohort Study — Feles & Mattner, JMIR research protocols · source ↗

• stool
• self-collection
• dct
• microbiome

This study validated a low-cost 3D-printed smartphone attachment and paper sensor for measuring glucose, uric acid and cholesterol in saliva, demonstrating high correlation with standard ELISA results in a small clinical cohort. The authors suggest this platform offers a scalable solution for decentralised diabetes management by balancing sensitivity with affordability.

Nanostructured zinc-coordination supraparticles on cellulose fibers: A 3D-Printed μ-FAD integrated smartphone platform for multiplexed salivary metabolic monitoring — Yang et al., Biosensors & bioelectronics (paywalled) · source ↗

• dct
• economics
• metabolome
• self-collection
• liquid
• validation
• saliva