Giving patients choices: AstraZeneca's evolving approach to patient-centric sampling
Bailey et al.
The finding, in our words
AstraZeneca's two case studies showed that reduced pharmacokinetic sampling schedules and composite plasma and dried-blood profiles in patient-centric trials maintained outcomes while lowering burden. This validates decentralised therapeutic drug monitoring and haematocrit modelling, but success demands organisational collaboration and accepting that no single device fits all patients.
A paraphrase to the Library’s standard, never the abstract. The source is one link away and is always the authority.
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.
In 55 patients, four approaches to convert dried capillary blood concentrations to plasma equivalents were evaluated. All methods except haematocrit-based conversion yielded acceptable analytical and clinical agreement for paracetamol and metabolites, supporting the reliability of capillary microsampling for decentralised therapeutic drug monitoring.
Boffel et al., The AAPS journal (paywalled) · source ↗
Capillary blood collection using liquid and dried microsampling devices yielded pharmacokinetic profiles comparable to venous sampling for two monoclonal antibodies and a small molecule, whereas haematocrit correction was necessary for dried formats and bridging was ineffective for hydroxychloroquine. The findings demonstrate the bioanalytical feasibility and patient acceptability of remote microsampling tools for pharmacokinetic evaluations in decentralised clinical trials.
Mandlekar et al., Clinical pharmacology and therapeutics (paywalled) · source ↗
The authors developed and validated a workflow that couples Mitra volumetric absorptive microsampling with hybridisation LC-MS/MS to quantify the antisense oligonucleotide fomivirsen in human blood. Quantitative recovery was achieved irrespective of haematocrit level or sample age, and the method demonstrated sensitivity, linearity, precision, accuracy, and four-month stability, supporting its use for therapeutic drug monitoring of biologic candidates in decentralised trials.
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 ↗