Implementing a clinical research coordinator–led care delivery model (CRC model) in an early-phase oncology program: A pilot to streamline workflow, improve collaboration, and enhance patient-centered trial conduct.

Abstract

1585 Background: Early-phase oncology trials involve medically complex patients with narrow enrollment windows. Traditionally, CRC roles focused on data management and scheduling, with limited integration into visit-based workflows, creating gaps in protocol execution and prescreening. This pilot embedded CRCs into patient-facing workflows to improve visit preparedness, protocol reliability, and enrollment readiness in biomarker-driven Phase I trials. Methods: CRCs were embedded alongside investigators and research nurses during patient visits to support coordination of protocol requirements. This included standardized patient schedule education; CRC-led week-ahead planning; proactive symptom monitoring with escalation pathways; multidisciplinary supportive care coordination; and prescreening/enrollment support for biomarker-driven trials, including tissue tracking and coordination of enrollment-sensitive testing timelines. A pre- and post-evaluation was conducted. Active patients during matched 8-month pre- and post-implementation periods were identified through a CRC-maintained prescreening tracker and electronic health record review. Protocol deviations were categorized by primary attribution. Visit preparedness, timeliness of symptom escalation, supportive care coordination, and prescreening workflow adoption were assessed. Statistical significance was evaluated using the Wilcoxon signed-rank test. Results: Scheduling protocol deviations decreased from 42 pre- to 20 post-implementation (52% reduction), driven by fewer missed or delayed assessments and communication gaps. CRC-led week-ahead reviews improved visit preparedness, with assessment-related deviations decreasing from 37 to 4 over matched 8-month periods (~89% reduction). CRC presence centralized protocol and logistical oversight, supporting timely trial readiness in Phase I. CRC-led prescreening improved visibility into tissue availability, biomarker testing status, and cohort eligibility. Mean time to tissue submission decreased from 9 business days pre-implementation (range, 2–25; n = 20) to 2.2 business days post-implementation (range, 1–4; n = 20; p = 3.54 × 10⁻⁵). Across three tissue-dependent interventional trials, identification of patients meeting protocol-specified eligibility criteria increased from 39 to 59 over matched 8-month periods (51.3% increase). Conclusions: Adopting a CRC model improved operational reliability and prescreening efficiency, enabling faster tissue submission, quicker identification of biomarker-eligible patients, and top of scope team function. Programs facing trial complexity or staffing constraints may benefit from CRCs in visit support and prescreening roles to improve efficiency and trial access.