Leveraging patient‐centric sampling for clinical drug development and decentralized clinical trials: Promise to reality
Katie F. Maass, Matthew Barfield, Mototsugu Ito, Christopher James, Olga Kavetska, Marc Kozinn, Kumar Parag, Maureen Lepak, Luc Alexis Leuthold, Wenkui Li, Д. А. Михайлов, Shefali Patel, Nisha Perez, Deanne Jackson Rudd, Blisse Vakkalagadda, Tracy M. Williams, Jiuhong Zha, Xin Zhang, Melanie Anderson
Abstract
Advances in the technologies to enable patient-centric sampling (PCS) have the potential to improve blood sample collection by enabling clinical trial participants to collect samples via self-collection or with the help of a caregiver in their home. Typically, blood samples to assess pharmacokinetics and pharmacodynamics of a drug during clinical development are collected at a clinical site via venous blood draw. In this position paper by the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), the potential value PCS can bring to patients, to the clinical datasets generated, and to clinical trial sponsors is discussed, along with considerations for program decision making, bioanalytical feasibility, operations, and regulatory implications. With an understanding of the value of PCS and considerations when implementing during clinical drug development, we can bring the promise of PCS closer to reality and enable decentralized clinical trials.