2025 · The AAPS Journal · paywalled
Patel et al.
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.
2025
A 2025 review maps 28 microsampling devices, from dried spots and volumetric absorptive tips to upper-arm liquid capillary collectors, and names what a laboratory must control before their results are used: the haematocrit effect in non-volumetric dried samples, interstitial fluid from finger milking, volume, haemolysis and transport stability. Regulators on both sides of the Atlantic ask for the same two things, a device the patient can use safely and a sample fit for the test.
Spooner et al., Bioanalysis · source ↗
2022
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”.
Maass et al., Clinical and Translational Science · source ↗
2025
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.
Hendriks et al., Diabetes care (paywalled) · source ↗
2025
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.
Hober et al., Analytical chemistry · source ↗
2021
Merck describes a digitally enabled, patient-centric trial initiative that combines outpatient PK/PD sampling with digital biomarkers and smart dosing technologies to improve exposure-response understanding and reduce patient burden, while acknowledging adoption challenges.
Dockendorf et al., Clinical and translational science · source ↗