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Clinical Research Coordinator Analysis

Visit Procedures (Meal Tolerance Test)

Finding: The Meal Tolerance Test (MTT) scheduled for Day 1 (Visit 2) and Week 26/End of Treatment (Visit 9), as detailed in Section 8.2.3.3, presents a significant logistical burden for the site and a considerable time commitment for participants. The procedure requires an 8-hour fast, consumption of a standardized liquid meal within 10 minutes, followed by 9 timed blood draws over approximately 4 hours and 15 minutes. This translates to participants being at the site for at least 5-6 hours, demanding meticulous scheduling, dedicated staff for precise timing of draws and meal administration, and clear management of participant expectations to ensure compliance and comfort. Recommendation: To proactively manage these demanding visits, sites should:

1. Develop a detailed, site-specific Standard Operating Procedure (SOP) or checklist for MTT visit days, outlining specific staff responsibilities, a minute-by-minute schedule for meal administration and blood draws, and pre-visit preparation steps (e.g., confirming fasting, preparing the standardized meal).

2. During the informed consent process and again as a reminder before Visit 2 and Visit 9, thoroughly explain the entire MTT procedure, duration, and fasting requirements to participants. Offer suggestions for their comfort during the long visit (e.g., bringing a book, dedicated quiet space).

3. Block dedicated clinic time and personnel (phlebotomist, coordinator) specifically for MTT visits to prevent scheduling conflicts and ensure all timed procedures are met accurately without rushing.

4. Confirm availability and proper storage of the standardized meal (Boost® Original liquid formula) well in advance and ensure it is prepared/served as per protocol instructions.

Rationale: Implementing these measures will enhance participant adherence and satisfaction by managing expectations and providing a more comfortable experience, ensure the integrity and accuracy of the valuable pharmacokinetic and pharmacodynamic data collected during the MTT, reduce the risk of protocol deviations related to incorrect timing or procedure, and allow for efficient site resource planning.