3521 - Implementation of a Radiation Oncology Protocol Committee for Clinical Trial Review and Prioritization

M. Jin¹, M. Iocolano², W. Xu², M. Kim², W. A. Paez³, S. J. Feigenberg², P. E. Gabriel², C. Koumenis², E. Ben-Josef², and J. P. Plastaras²; ¹The Pennsylvania State University, University Park, PA, ²Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, ³Fox Chase Cancer Center, Philadelphia, PA

Purpose/Objective(s): The conduct of prospective clinical research that aligns with the mission of an academic radiation oncology department is critical. As compared to retrospective research efforts, prospective studies typically demand considerable investment of departmental resources. In order to streamline the approval of highly prioritized, strategically aligned, high quality prospective research, an academic radiation oncology department created the Radiation Oncology Protocol Committee (ROPC). Materials/

Methods: An online ROPC database application system was developed for evaluation of clinical trial proposals. Submissions required a hypothesis, trial design, statistical plan, draft protocol, and budget, if available. Submissions were categorized into six priority levels based on alignment with department strategy, investigator role, and funding. Within 4 weeks, two department-assigned reviewers determined by expertise evaluated proposals. The ROPC then convened to discuss and determine approval.

Results: From 3/2013 to 2/2024, 108 total protocols were submitted to the ROPC database, of which 44% were pilot studies, 9.3% were Phase I, 29% were Phase II and 19% were Phase III. Of the listed principal investigators, 105 were MDs, 2 were physicists and 1 was a biologist. Of 107 proposals with stated accrual goals, the median target sample size was 40 patients (range 4-3000 patients). Most protocols were prioritized as category 2 (31.5%) followed by category 1 (24%) and category 6 (16.7%) (Table 1). Following the creation of the ROPC, all prospective protocols using departmental resources required prior approval of the committee.

Conclusion: Following the creation of the ROPC, approximately 39% of submitted protocols aligned with departmental strategic plan priorities. Furthermore, the use of an online database facilitated submission organization and monitoring by the ROPC. The review system can enhance clinical research efforts and ensure the appropriate allocation of departmental resources.

Abstract 3521 – Table 1: ROPC protocol priority categorization

Category	Protocol N (%)
1: Peer-reviewed grant or foundation-funded trial based on PI concept.	26 (24)
2: PI-initiated trial with partial funding support; Study falls under a departmental main theme of research.	34 (31.5)
3: PI-initiated trial with partial funding support; Study is outside departmental main themes of research.	3 (2.8)
4: PI-initiated trial with no funding support; Study falls under a departmental main theme of research.	8 (7.4)
5: Contract or cooperative group study led by or extending a concept developed by the PI.	16 (14.8)
6: PI-initiated trial with no funding support; Study is outside departmental main themes of research or is a multi-center trial coordinated elsewhere.	18 (16.7)
Unspecified	3 (2.8)