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Clinical Research Coordinator Analysis

Cycle 1 Day 1 Pharmacokinetic (PK) Sample Collection

Finding: The protocol (Table 1, footnote 'f'; Section 6.4.1) specifies PK blood sample collection on Cycle 1 Day 1 (C1D1) at predose, and 1, 2, 4, 6, 8, and 24 hours post-dose. The 24-hour post-dose sample, in particular, presents a significant logistical challenge and burden for both participants and site staff. The protocol lacks clarity on the practical execution of this 24-hour sample, such as whether it requires a separate visit on C1D2 or if there's an acceptable collection window, potentially impacting resource allocation, participant adherence, and data quality. Recommendation: We recommend the Sponsor provide explicit guidance in the protocol or study operations manual regarding the C1D1 24-hour post-dose PK sample collection. Specifically:

1. Define an acceptable collection window (e.g., 24 ± 2 hours) for the 24-hour sample.

2. Clarify if the participant must return to the clinic on Cycle 1 Day 2 for this sample. If a return visit is necessary, ensure this visit is formally recognized in the Schedule of Activities, and that associated participant time and travel are appropriately addressed in reimbursement plans.

3. To facilitate planning, provide guidance on optimal C1D1 dosing times (e.g., encouraging early morning administration if a C1D2 return is expected).

4. If scientifically justifiable and logistically feasible, consider if alternative collection methods for the 24-hour sample (e.g., certified home health visit, if available and appropriate for the participant population and sample integrity requirements) could be an option for select sites/participants.

Rationale: Clear, upfront guidance on the 24-hour PK sample logistics will significantly improve site operational planning and resource allocation for C1D1/C1D2, enhance the participant experience by setting clear expectations and minimizing inconvenience, reduce the risk of protocol deviations related to out-of-window or missed PK samples, and ultimately ensure the collection of high-quality pharmacokinetic data crucial for achieving the study's objectives.