Opportunities and Challenges for Decentralized Clinical Trial Approaches: European Health Technology Assessment Perspective

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

An evaluation of blood sampling strategies across a large UK healthcare-worker cohort study, covering how sampling approach affected participation.

Evaluating blood sampling strategies within the SIREN study: the experience from a large cohort of healthcare workers in the UK — Hettiarachchi et al., BMC Medical Research Methodology · source ↗

• dct
• acceptability
• blood
• economics
• self-collection
• capillary
• validation

Interviews with clinical development staff found that decentralised clinical trials improved patient access by reducing travel burdens and waiting times. Implementation challenges included local regulations, telemedicine policies, IT infrastructure, information literacy and costs, with Japan lagging behind Europe and the United States in adoption.

Considerations on the implementation of DCT: a SCAT-based analysis of fact-finding interviews in Europe and the United States, with implications for regions newly adopting DCT, including Japan — Taruno et al., Frontiers in medicine · source ↗

• dct
• economics

Decentralised recruitment channels generated 97.5% of enrolments, were cost effective, and met timelines, with 82.6% retention at six months, showing that decentralised strategies are feasible and conducive to achieving enrolment targets.

Recruitment, Retention, and Participant Diversity in the Context of a Heart Failure Self-Care Digital Intervention Decentralized Clinical Trial — West et al., AMIA ... Annual Symposium proceedings. AMIA Symposium (paywalled) · source ↗

• dct
• economics

A digital decentralised clinical trial platform for long COVID successfully managed e-consent, randomisation, and data capture, but faced significant challenges including recruitment difficulties, imposter participants, and high attrition rates. These findings highlight critical considerations for designing viable remote trials in complex syndromes.

Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID — McMullan et al., Scientific reports · source ↗

• dct
• economics