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.
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.
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.
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.
The review highlights that volumetric absorptive microsampling enables easy, minimally invasive home sampling with room temperature storage and fixed volume accuracy, making it a viable alternative for clinical trials and therapeutic drug monitoring during the COVID-19 pandemic.
In AML and CLL, 91% of VAMS venetoclax results fell within 20% of plasma after individualised haematocrit correction; in home sampling, 18 of 21 patients self-sampled independently and 76% of returned samples were analysable, which shows home microsampling is workable, though the authors ask for multicentre validation.