1016 - The Development of the Protocol Review and Monitoring System (PRMS) and Other Initiatives to Establish a Sustainable Culture of Clinical and Translational Research (CTR) at an Academic Cancer Center (ACC)

Purpose/Objective(s): We undertook a number of programmatic initiatives to improve accruals to interventional clinical trials (ICT) & increase the efficiencies of our clinical trial (CT) enterprise with the long term goal of establishing a sustainable culture of CTR at our ACC. The objective of our retrospective analysis was to determine the impact of our initiatives on accruals & PRMS activities.

Materials/Methods: Between 2021 and 2024, our initiatives were as follows: (1) CT portfolio analysis: (2) Baseline faculty survey; (3) Development of a "One-Pager" list of active CT; (4) Working with faculty "champions" to improve accruals; (5) Increasing our research staff in the Clinical Trials Office (CTO); (6) Initiation of a "Clinical Trials Working Group" regular meeting involving key stakeholders to manage our CT portfolio; (7) Development of specific "Disease Working Groups (DWGs)" to establish a "Protocol Review and Monitoring System" (PRMS); (8) Working with the PRMS to only open those CT most suitable for our patient population; (9) Initiation of a monthly “Investigator Education Workshop” (IEW); (10) Annual acknowledgements (e.g., "Top Enrolling Ceremony") for our investigators.

Results: The CTO staffing was increased from 7 to 11 FTEs. Between October 2021 and 2024, the PRMS was developed by establishing 7 DWGs (i.e., Breast, GU, GI, GYN-Onc., Thoracic, CNS & Head / Neck) and reconstituting the Protocol Review & Monitoring Committee (PRMC). The analysis of our CT portfolio indicated significant improvement in the overall enrollment status to ICT between December 2020 and December 2024 as a result of establishing the PRMS (Table 1). For example, half [i.e., 50% (n=16/32)] of the active ICT had never enrolled a patient in their lifetime as of Dec. 2020, which was significantly reduced over time to only 11% (n=4/35) by Dec. 2024. A similar pattern was observed for accruals to ICT that had not enrolled patients the previous year, with a significant decrease from 59% (n=17/29) in Jan. 2022 to 23% (n=8/35) by Dec. 2024 (Table 1). In addition, enrollments to ICT were also significantly increased between historical controls (2016-2020) vs. recent post-PRMS implementation (2021-2024), respectively, from an overall institutional annual accrual average of 42 to 108 patients, [p=0.0083] and a CTO-supported annual accrual average from 25 to 40 patients, [p=0.0225].

Conclusion: The development of the PRMS along with our other initiatives within the last 4 years has culminated in a significant increase in enrollments to our ICT and a more efficient clinical trial enterprise resulting in a sustainable culture of CTR at our academic cancer center.