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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 hematocrit and 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 life cycle and accepting that if the aim is to give patient choice, then one solution (device, procedure and design) will not fit all.
Acknowledgments
The authors would like to formally acknowledge the contribution of J Rudge of Neoteryx, Inc., for the guidance provided for implementing the use of the Mitra™ VAMS® microsampling devices and the contribution of P Severin and G Dufour of Covance Laboratories in the provision of the VAMS-based assays for analysis of the pharmacokinetic and pharmacodynamic samples from the two case studies cited in this article.
Financial & competing interests disclosure
At the time of writing this manuscript, all authors were employees of AstraZeneca and all held AstraZeneca shares. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.