Protocol Review and Monitoring System

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PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT The University of Florida Health Cancer Center (UFHCC) Protocol Review and Monitoring System (PRMS) is responsible for scientific evaluation, prioritization, and monitoring of all cancer-relevant clinical research conducted by the UFHCC. The overall goal of the PRMS is to ensure that the clinical research portfolio consists of impactful and scientifically sound studies aligned with the UFHCC strategic vision. All PRMS activities are coordinated by the UFHCC Clinical Research Office. UFHCC uses a 2-stage process consisting of Disease Site Group (DSG) and Scientific Review and Monitoring Committee (SRMC) reviews. The DSGs provide an integrated, multidisciplinary approach to guide the selection and endorsement of high-quality cancer clinical trials, while the SRMC reviews research studies for scientific merit, including study design, methodology, statistical analysis plan, accrual goal expectations, procedures to ensure participant safety, and institutional priority. A feasibility assessment is performed for all interventional studies to confirm there are a sufficient number of potential participants and adequate clinical resources. To facilitate mission alignment, the University of Florida mandates that all cancer-relevant research protocols must be reviewed and approved by the SRMC prior to Institutional Review Board (IRB) approval. Prior to SRMC submission, all interventional trials are reviewed by the appropriate DSG for scientific and clinical interest and relevance to the UFHCC catchment area. The latter is verified by the Director of the Office of Community Outreach and Engagement, who serves as a member of the SRMC. The SRMC focuses on scientific merit and study progress, and its function does not overlap with that of the IRB, whose jurisdiction is primarily participant safety. SRMC prioritizes trials competing for UFHCC resources or participants and has final authority on study approval/termination, without appeal. The SRMC conducts ongoing reviews of all active interventional clinical trials to ensure they are making sufficient scientific progress. The SRMC closes trials for inadequate accrual, loss of scientific merit, or protocol violations that compromise participant safety or the scientific integrity of a study. SRMC members are multidisciplinary to ensure a fair, critical review of proposed cancer clinical studies. Membership includes faculty and staff with expertise in clinical investigation, biostatistics, research pharmacy, clinical care, nursing, laboratory, biobehavioral and population science, and Citizen Scientists. In 2021, DSGs considered 238 new clinical research studies, ultimately bringing 86 (36%) to the SRMC, of which 53 were approved, 29 were approved with stipulations, and 4 were tabled. None were disapproved, due largely to rigor of the DSG review process. In 2021, the SRMC also completed 66 protocol amendment reviews and 131 continuation reviews. The continuation reviews resulted in 76 approvals, 34 probationary approvals, and 21 terminations. Most probationary approvals were related to challenges with enrollment resulting from the COVID-19 pandemic. Future directions include shortening timelines for SRMC approval, paperless documentation, and optimization of catchment area impact.