In recent years, significant advancements in technology and regulatory understanding have made patient-centric sampling (PCS) a feasible option for clinical studies, particularly when it aligns with strong business sense. By enabling decentralization of clinical trials, PCS can provide patients with greater convenience, reduced travel time to clinical sites, and less invasive sampling. This is especially beneficial for studies in remote rural areas or for pediatric studies. Additionally, from a sponsor's perspective, PCS can increase the diversity of study design and reduce study costs.
In this presentation, we will showcase GSK's efforts in developing bioanalytical strategies for PCS samples. The first case study introduces the development and validation of an LC-MS based PK assay for a GSK drug in dried human blood collected with a volumetric absorptive microsampler (VAMS®) Mitra Device. The assay exhibited excellent precision and accuracy due to the device’s highly consistent volumetric capacity. The quantitation was found not impacted by extreme blood hematocrit levels. The assay was used in the analysis of clinical samples in a regulated environment and demonstrated highly consistent PK profiles across subjects. Additionally, incurred sample reanalysis (ISR) all passed with low biases. One major challenge encountered was the reduced extractability from long-term storage samples, which will be discussed in further detail. The second case study also discusses an LC-MS based PK assay, but with the Tasso-M20, a patient-friendly device especially suitable for pediatric studies. We will discuss the sample preparation and analytical performance of this device.
Finally, we will compare the method validation and sample analysis between the PCS and routine wet matrix assay, highlighting differences and providing insights for future development.
Learning Objectives:
Describe the benefits of PCS in clinical studies and define the bioanalytical strategies for PCS sample collection and analysis using the VAMS® Mitra Device and the Tasso-M20 device.
Understand the general workflow to conduct an LC-MS based PK assay for PCS samples and identify the major challenges encountered during PCS sample analysis.
Identify the major differences of method validation and sample analysis between PCS and traditional wet matrix assays.