PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM The Sylvester Comprehensive Cancer Center (Sylvester) Protocol Review and Monitoring System (PRMS) is the centralized authority which oversees and provides independent, peer review of the scientific merit, priority, and progress of all prospective, hypothesis-driven clinical cancer research involving human subjects conducted at the University of Miami (University). PRMS functions are accomplished by a rigorous two-stage review process. The site disease groups (SDGs) and clinical research teams (CRTs) perform the initial, Stage 1 PRMS review of potential clinical impact, scientific importance, catchment area (CA)-relevance, and overall prioritization within the existing portfolio of SDG/CRT studies, as well as assessing each study’s operational and accrual feasibility. The Stage 2 PRMS review by the PRMC is the definitive, independent, centralized authority for determining which studies proceed to activation, and which ongoing studies remain active, based on scientific and clinical merit and accrual progress. The activities of the PRMC are independent and non- overlapping with the University’s Institutional Review Board (IRB). Prioritization and approval by the SDG/CRT are required before a study proceeds to the PRMC; however, only the PRMC has final and independent authority to determine which studies will be activated and which underperforming studies will be closed. The specific aims of the PRMC are to 1) assess the scientific merit of proposed cancer research studies through robust scientific peer review; 2) prioritize all cancer studies according to Sylvester’s Strategic Plan, mission, CA-relevance, and Research Programs; 3) confirm that appropriate subject recruitment plans are in place, target accrual predictions are achievable, and adequate data and safety monitoring plans are defined; and 4) monitor scientific progress with final authority to terminate cancer studies not meeting accrual goals. To accomplish these aims, the PRMC ensures that all clinical cancer research studies involving human subjects are scientifically robust, have appropriate biostatistics, and are prioritized within Sylvester’s research portfolio. The PRMC also ensures that protocols are aligned with Sylvester’s Strategic Plan for clinical research, are feasible for completion and meeting specified accrual goals within timeline, have an appropriate data and safety monitoring plan, and are monitored regularly for accrual, clinical, and scientific progress. During the reporting period (6/1/2018 to 5/31/2023), the Sylvester SDG/CRTs approved 691 protocols for PRMC review. Once received by the PRMC, 244 of the 691 studies (35%) received an initial expedited review by the PRMC Chair, while 447 of the 691 studies (65%), primarily Sylvester’s investigator-initiated and industry-sponsored studies, were forwarded for full PRMC review. The PRMC closed 49 underperforming studies and facilitated the closure of an additional 47...