Abstract
This paper shares experiences and learning from introducing patient-centric sampling (PCS) into AstraZeneca trials. Through two case studies we show how modeling approaches can assist pharmacokinetic (PK) bridging studies accounting for blood partitioning and hematocritand how reduced PK sampling schedules, profiles constructed from composite data (plasma & dry blood) and combined assays (PK & pharmacodynamic) can all reduce patient sampling burden without impacting study outcomes. Following sharing some clinical operational challenges, we finally highlight some key requirements for implementing a patient-centric sampling strategy such as collaborative working across organizational silos, continuous patient engagement throughout the study lifecycle and accepting that if the aim is to give patient choice, then one solution (device, procedure and design) will not fit all.
Published Version
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