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Clinical Research Coordinator Analysis

Screening Procedures & Participant Burden

Finding: The protocol mandates a fresh tumor biopsy during the screening period if archival tissue (collected within 5 years, unless it is the most recent biopsy) is unavailable or deemed insufficient (e.g., <10% tumor cells, QNS) for KRAS G12C testing (Section 6.2.1, page 43). While crucial for eligibility confirmation, coordinating fresh biopsies frequently presents significant logistical challenges for sites, including scheduling with interventional radiology/surgery and pathology, managing participant anxiety and discomfort associated with an additional invasive procedure, and potentially extending screening timelines, which can impact enrollment pace. Recommendation:

1. During site initiation and training, proactively discuss and map out the site-specific pathways for obtaining fresh tumor biopsies. This should include identifying key personnel in relevant departments (e.g., Interventional Radiology, Surgery, Pathology), estimated turnaround times, and any pre-authorization or specialized scheduling requirements.

2. The Sponsor/CRO could develop a "Biopsy Best Practices Guide" or toolkit for sites. This guide should detail optimal biopsy techniques for yielding sufficient tissue, minimum tissue core requirements, preferred anatomical sites if applicable, and explicit sample handling/preservation instructions to ensure sample integrity for central lab analysis, thereby minimizing the risk of repeat biopsies.

3. Encourage sites to implement a pre-screening checklist to assess archival tissue availability and potential suitability (e.g., date of collection, original pathology report details) *as early as possible* when a potential participant is identified. This allows for earlier submission of archival tissue to the central lab (or assessment by local lab if used) and, if necessary, earlier planning for a fresh biopsy.

4. Provide patient-facing materials that clearly explain the potential need for a fresh biopsy, the reasons why it might be necessary (importance of KRAS G12C confirmation for personalized treatment), what the procedure typically entails, and address common concerns. This can help manage participant expectations and reduce anxiety.

Rationale: Implementing these proactive measures will help streamline the biopsy process, reduce avoidable delays in screening, minimize the burden and anxiety for participants, improve the quality and success rate of tissue acquisition for essential biomarker testing, and ultimately support more efficient and timely trial enrollment.