2022 · Clinical and Translational Science · open access
Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality
Maass et al.
The finding, in our words
An IQ Consortium position paper from sponsor scientists positioning patient-centric sampling as the enabling technology for decentralised trials, and stating that a bridging study against conventional sampling “has quickly been established as a regulatory expectation”.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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 UK consensus opinion outlines how clinical laboratories can validate self-collected capillary blood sampling against venous reference standards to achieve accreditation and facilitate the shift towards community-based patient care.
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.