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Clinical Research Coordinator Analysis

Baseline Visit (Day 1) Procedures - PK Sampling

Finding: The protocol mandates Pharmacokinetic (PK) blood sampling at pre-dose, and 2, 4, and 8 hours post-dose on Day 1 (Visit 2) for participants randomized to the PF-06651600 arm (Protocol Section 8.2.1, page 41). This creates a significant logistical burden for the site, requiring extended participant presence (over 8 hours) and dedicated staff availability for precisely timed procedures throughout a full day, potentially impacting clinic workflow and participant experience. Recommendation:

1. Develop a detailed Day 1 participant flow checklist and schedule template specifically for participants anticipated to undergo the extended PK sampling. This should allocate dedicated CRC/phlebotomy staff for the timed PK draws and subsequent sample processing.

2. Attempt to schedule these participants as the first appointment of the day to minimize potential for compounding delays from other clinic activities.

3. Prepare a designated comfortable waiting area for these participants. Communicate clearly with participants during consenting and prior to Day 1 about the extended visit duration and advise them to bring books, work, or other quiet activities. Clarify if the site or sponsor will provide meals/refreshments or if participants should bring their own.

4. Ensure all lab processing instructions for timed PK samples are thoroughly reviewed with lab staff, and that all necessary collection tubes, processing supplies, and shipping kits for all 4 draws are pre-assembled and labeled for each participant before their arrival.

Rationale: Proactive planning and dedicated resource allocation for these extended Day 1 visits will reduce the risk of missed PK samples or out-of-window collections (protocol deviations), improve participant satisfaction by managing expectations and providing a more organized experience, and ensure efficient use of site staff and resources.