Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, AstraZeneca, Cambridge, UK.
Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, AstraZeneca, Gothenburg, Sweden.
Bioanalysis. 2020 Jul;12(13):957-970. doi: 10.4155/bio-2020-0105. Epub 2020 Jul 27.
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.
本文分享了将以患者为中心的采样（PCS）引入阿斯利康试验的经验和教训。通过两个案例研究，我们展示了建模方法如何帮助药代动力学（PK）桥接研究考虑血液分配和血细胞比容，以及如何减少 PK 采样方案、从组合数据（血浆和干血）构建的图谱和联合检测（PK 和药效动力学）都可以在不影响研究结果的情况下减轻患者采样负担。在分享了一些临床操作方面的挑战之后，我们最后强调了实施以患者为中心的采样策略的一些关键要求，例如跨组织孤岛的协作工作、在整个研究生命周期中持续的患者参与以及接受这样一个事实，如果目标是给患者选择，那么一种解决方案（设备、程序和设计）将不会适合所有人。
