Unlock the power to be your own CRO.

Clinical Research Coordinator Analysis

6MWT Administration & Site Logistics

Finding: The protocol's requirement (p.37) for the 6-Minute Walk Test (6MWT) to be conducted in a "long, flat, straight, enclosed corridor... that is seldom used for other purposes" presents a potential logistical hurdle. Many clinical sites, particularly those in busy hospital settings, may struggle to consistently secure a corridor meeting the "seldom used" criterion, potentially leading to interruptions, environmental variability, or scheduling difficulties for this key efficacy assessment. Recommendation: During site feasibility and startup, proactively identify and formally designate a primary 6MWT corridor that strictly adheres to protocol and American Thoracic Society (ATS) guidelines. Develop a contingency plan by identifying a compliant backup corridor. We recommend the Sponsor provide a site checklist for corridor assessment, including practical interpretations of "seldom used" (e.g., ability to reserve/restrict access for the duration of the test), to ensure consistent application and understanding across all participating sites. Rationale: This proactive planning and clarification will help ensure consistent, high-quality 6MWT data, minimize the risk of protocol deviations related to the testing environment, and streamline participant visit scheduling, ultimately supporting the integrity of this primary efficacy endpoint.