Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges
Kijewski et al.
The finding, in our words
This study found that most decentralised clinical trials are still focused on evaluating methods rather than fully implementing them, with digital tools often used to deliver study activities. The work highlights the need for stronger methodological validation, regulatory clarity, and attention to digital equity to advance decentralised diagnostics.
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.
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.
Low-volume blood collection devices enable frequent, longitudinal sampling at home with reduced invasiveness, thereby improving participant retention in patient-centric studies. This facilitates decentralised biomarker monitoring for tracking disease progression and understanding physiological responses to diet, medication and physical activity.
This narrative review surveys remote biospecimen collection products for sexual health research, including dried blood spots and volumetric absorptive microsampling, and concludes that successful implementation needs a multidisciplinary, participant-centred team with sufficient time allocated to the complexities of collection procedures and processes.