Considerations for Implementation of Microsampling in Pediatric Clinical Research and Patient Care

Moorthy, Ganesh S.; Vedar, Christina; Zuppa, Athena F.

doi:10.1002/9781119615583.ch7

Cited by 1 publication

(2 citation statements)

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“…It is particularly advantageous for remote rural studies, where fewer clinical sites exist and travel can be challenging, and for pediatric studies, as PCS minimizes patient discomfort. 8,9 PCS also facilitates the collection of samples for clinical endpoints that are episodic and unpredictable such as migraine, asthma, or adverse events. 10 Such PCS capabilities enable the biomarker analysis of samples near clinical events and facilitate the exposure-response analysis.…”

Section: Advancing Clinical Studies With Pcsmentioning

confidence: 99%

“…This approach facilitates the decentralization of clinical trials, offering patients greater convenience, reduced travel time to clinical sites, and less invasive sampling. It is particularly advantageous for remote rural studies, where fewer clinical sites exist and travel can be challenging, and for pediatric studies, as PCS minimizes patient discomfort 8,9 . PCS also facilitates the collection of samples for clinical endpoints that are episodic and unpredictable such as migraine, asthma, or adverse events 10 .…”

Section: Advancing Clinical Studies With Pcsmentioning

confidence: 99%

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Enhancing drug development and clinical studies with patient‐centric sampling using microsampling techniques: Opportunities, challenges, and insights into liquid chromatography‐mass spectrometry strategies

Chen,

Goudarzi,

Sikorski

et al. 2024

J Mass Spectrom

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Microsampling has revolutionized pharmaceutical drug development and clinical research by reducing sample volume requirements, allowing sample collection at home or nontraditional sites, minimizing animal and patient burden, and enabling more flexible study designs. This perspective paper discusses the transformative impact of microsampling and patient‐centric sampling (PCS) techniques, emphasizing their advantages in drug development and clinical trials. We highlight the integration of liquid chromatography‐mass spectrometry (LC–MS) strategies for analyzing PCS samples, focusing on our research experience and a review of current literatures. The paper reviews commercially available PCS devices, their regulatory status, and their application in clinical trials, underscoring the benefits of PCS in expanding patient enrollment diversity and improving study designs. We also address the operational challenges of implementing PCS, including the need for bridging studies to ensure data comparability between traditional and microsampling methods, and the analytical challenges posed by PCS samples. The paper proposes future directions for PCS, including the development of global regulatory standards, technological advancements to enhance user experience, the increased concern of sustainability and patient data privacy, and the integration of PCS with other technologies for improved performance in drug development and clinical studies. By advancing microsampling and PCS techniques, we aim to foster patient‐centric approaches in pharmaceutical sciences, ultimately enhancing patient care and treatment efficacy.

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Section: Advancing Clinical Studies With Pcsmentioning

confidence: 99%

Section: Advancing Clinical Studies With Pcsmentioning

confidence: 99%