Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality

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.

FIGURE 1

Considerations for patient‐centric sampling including overall program strategy (a) and operational, regulatory, and bioanalytical considerations that may present challenges (b). PCS, patient‐centric sampling; PD, pharmacodynamic; PK, pharmacokinetic