Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development
Patel et al.
The finding, in our words
Worked case studies of patient-centric sampling deployed in pharmaceutical drug development: how sponsors have implemented it, rather than whether it is possible.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
A study of 292 patients found that the slopes of home-collected stimulated dried blood spot C-peptide levels over six months predicted 12-month venous mixed-meal tolerance test results, P<0.001. This shows decentralised microsampling can monitor beta-cell function, though further validation is required to confirm its reliability and broader applicability.
Targeted proteomic evaluation of a novel finger-prick dried plasma device demonstrated strong quantitative correlation with conventional plasma (R = 0.99) and precision under 10% CV for 80% of quantified peptides across healthy donors. Quantified targets also remained stable during room temperature storage for up to 232 days, supporting its use for decentralised biomarker monitoring.
Capillary dried blood spots, after haematocrit-dependent conversion, showed good agreement with plasma for 25-hydroxyvitamin D quantification, with 90 per cent of results within 20 per cent of plasma and substantial to almost perfect agreement in status classification, supporting reliable home self-collection for large-scale vitamin D monitoring.
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.
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.