Giving patients choices: AstraZeneca's evolving approach to patient-centric sampling

Area of Science:

• Clinical Pharmacology
• Pharmacokinetics
• Drug Development

Background:

• Traditional clinical trial sampling methods can impose a significant burden on patients.
• Optimizing sampling strategies is crucial for improving patient experience and trial efficiency.
• Patient-centric sampling (PCS) offers a novel approach to minimize invasiveness and inconvenience.

Purpose of the Study:

• To share experiences and learnings from implementing patient-centric sampling (PCS) in AstraZeneca clinical trials.
• To demonstrate how modeling approaches can support pharmacokinetic (PK) bridging studies.
• To evaluate methods for reducing patient sampling burden without compromising study outcomes.

Main Methods:

• Utilized two case studies to illustrate the application of PCS.
• Employed pharmacokinetic (PK) modeling to account for blood partitioning and hematocrit.
• Investigated reduced PK sampling schedules, composite data (plasma & dry blood), and combined PK/pharmacodynamic assays.

Main Results:

• Modeling approaches successfully assisted pharmacokinetic (PK) bridging studies.
• Reduced sampling schedules, composite data, and combined assays effectively lowered patient burden.
• Study outcomes were not negatively impacted by the implemented PCS strategies.

Conclusions:

• Patient-centric sampling (PCS) strategies can successfully reduce patient burden in clinical trials.
• Key requirements for PCS implementation include cross-functional collaboration, continuous patient engagement, and flexible, individualized solutions.
• A flexible, patient-centered approach is essential for successful PCS implementation, acknowledging that a one-size-fits-all solution is not feasible.