2022 · British Journal of Clinical Pharmacology · paywalled
A systematic review of methods used to conduct decentralised clinical trials
Rogers et al.
The finding, in our words
A systematic review of 19,704 articles, analysing 45 trials and 117 documents, found wide heterogeneity in decentralised clinical trial designs. The authors caution that there is currently insufficient evidence to confirm which decentralised methods are most effective for trial recruitment, retention, or overall cost.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
In a large decentralised hypertension trial of 21,104 adults, nearly half used their own home blood pressure monitors for remote monitoring, but 18.7% of identifiable devices lacked validation against standardised protocols despite costing substantially less than validated models. This reveals a critical gap in device quality for decentralised trials relying on patient-owned equipment.
A machine learning model called Remote Control was trained on 2685 blood samples to predict change due to instability, enabling accurate calibration of results to approximate the time zero value at collection. With calibration, unprocessed whole blood could be transported for up to 9 days under ambient conditions and temperatures between 3.4 and 47.4 degrees Celsius, achieving agreement with CLIA TEa between 98.1 and 100 per cent and expanding the catalog of tests available for at-home collection.
This developer study reports that a self-collection kit interfacing with a BD Microtainer produced RNA of sufficient quality and yield for transcriptomic analysis in a pilot group and a longitudinal rheumatology cohort. Most participants found the device easy to use, supporting its utility for decentralised blood sampling.