Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development.

The current gold standard of blood sample collection in clinical trials involves venous draws performed by trained phlebotomists in clinical settings. However, recent technological advancements have enabled the emergence of patient-centric sampling (PCS) methods, offering more flexible and accessible alternatives. This paper examines the motivation behind the pharmaceutical industry's growing interest in PCS devices and explores their application in drug development through seven case studies. The case studies highlight the benefits and practical challenges of PCS strategies, including remote (at-home) sample collection, use in pediatric populations, advantages during COVID-19 pandemic, and implementation across trials involving small molecules, biotherapeutics, biomarkers and vaccines. Several studies assess the concordance between traditional venous sampling and PCS methods, while also addressing logistical considerations for remote sampling with and without nurse support. A central theme across the case studies is the importance of designing trials that prioritize patient convenience and engagement. Examples such as an early-phase asthma trial exemplify how PCS can enhance study design. The findings underscore the clear advantages of PCS in improving trial recruitment, increasing participant diversity, minimizing discomfort, reducing sample volumes and enhancing operational efficiency. The paper provides practical insights and recent examples to guide the integration of PCS technologies into clinical trial protocols, emphasizing the value of early planning and strategic implementation.