Mikhailov, Dmitri, Li, Wenkui and Leuthold, Luc Alexis (2022) Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: promise to reality. Clinical Translational Sciences.

Abstract

As part of drug development, blood samples are often collected from clinical trial participants for assessment of pharmacokinetics (PK) and pharmacodynamics (PD). The current standard practice requires participants to travel to a clinical site to have blood drawn using a needle and vacutainer by a healthcare professional. However, a patient-centric sampling (PCS) approach could improve clinical trial participants’ experience of how, where, or when samples are collected without compromising the objective of trials and quality of bioanalytical data generated from the collected samples. Sample collection can be considered patient-centric if it is less invasive, less painful, requires lower blood volume, or if the collection could occur remotely, i.e. not at the clinical site, via self-collection by the trial participant, or with the help of a caregiver or at-home nurse. This novel approach has been strongly recommended by patient advocacy groups and encouraged as well by health regulatory authorities.

Item Type:	Article
Keywords:	smart sampling, decentralized trials, next generation trials, patient centric trials
Date Deposited:	18 Oct 2022 00:45
Last Modified:	18 Oct 2022 00:45
URI:	https://oak.novartis.com/id/eprint/47448