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Clinical Research Coordinator Analysis

Cycle 1 Pharmacokinetic (PK) Sample Collection Schedule

Finding: The pharmacokinetic (PK) sample collection schedule outlined in Section 7.3.3 and Appendix A for Cycle 1 is exceptionally demanding for both participants and site staff. Specifically, Cycle 1 Day 1 (C1D1) requires PK samples pre-dose, and at 1, 2, 4, 8, and 24 hours post-start of infusion. Furthermore, additional PK samples are required on "Day 2 (approx. 24 hr after the C1D1 24-hr sample)" and "Day 3 (approx. 48 hr after the C1D1 24-hr sample)". This effectively means study-related PK blood draws on four consecutive days (e.g., C1D1 infusion day, then calendar days 2, 3, and 4 for subsequent PKs). This intensity poses significant logistical challenges for outpatient scheduling, participant travel, and clinic resource management, particularly for the 24-hour C1D1 sample and the subsequent two daily samples, and increases participant burden substantially at the very start of the trial. The tight collection windows (e.g., ±5 minutes for early post-dose samples) add another layer of complexity. Recommendation:

1. Seek clarification from the Sponsor regarding the feasibility of managing the C1D1 24-hour sample and the subsequent "Day 2" and "Day 3" PK samples as outpatient visits. If outpatient, provide guidance on managing participant travel and accommodation needs, if any, due to the consecutive daily visits.

2. For site-level planning: Develop a detailed C1D1 through C1 "Day 3" PK visit workflow, including pre-allocation of staff for draws, preparation of PK kits well in advance, and robust participant education on this intensive initial schedule.

3. Evaluate if any flexibility can be introduced for the "Day 2" and "Day 3" PK sample timing or if these could be combined with any other (even unscheduled but necessary) patient contact, without compromising data integrity, to reduce the number of separate site visits.

Rationale: Improves adherence to critical PK sampling windows by anticipating logistical hurdles, reduces participant burden which can positively impact recruitment and retention, and allows for more efficient site resource allocation during a high-intensity period of the study.