Protocol Review and Monitoring System

PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT The Mayo Clinic Comprehensive Cancer Center (MCCCC) Protocol Review and Monitoring System (PRMS) assures rigorous internal oversight of the scientific aspects of all cancer clinical trials conducted at MCCCC. PRMS oversees all cancer clinical trials occurring across the Mayo Clinic Enterprise, at each of the three MCCCC sites (Mayo Clinic in Rochester (MCR), Mayo Clinic in Florida (MCF), and Mayo Clinic in Arizona (MCA)) as well as across the community-based Mayo Clinic Health System (MCHS). PRMS works in alignment with MCCCC Clinical Protocol and Data Management (CPDM), Data and Safety Monitoring (DSM), and the Mayo Clinic Institutional Review Board (IRB) but holds distinct and sole authorities and responsibilities for scientific protocol review, prioritization, activation, monitoring, and closure of underperforming trials. PRMS oversees two stages of protocol review. In the first stage (Stage 1), MCCCC Disease Groups (DGs) conduct initial scientific reviews of clinical trial protocols and work with PRMS to select and prioritize trials in their disease and discipline areas. Following approval by the DGs, one of two Protocol Review and Monitoring Committees (PRMCs) then conducts a second stage review (Stage 2), with rigorous statistical review of protocols, prioritization, and assessment of the overall clinical trial portfolio, ultimately leading to trial activation. The MCCCC DGs, PRMS, and Community Outreach and Engagement Office (COE) work collaboratively to assure that trial portfolios for each disease and discipline have the potential to accrue all patients including understudied populations in the MCCCC catchment areas, meet patient and community priorities and needs, and are aligned with the priorities of the MCCCC Strategic Plan. PRMCs also conduct continuing review of open protocols for accrual, modifications, and amendments, holding the sole authority to close trials that fail to accrue. DSM, with functions complementary but distinct from PRMS, continuously monitors trial safety information and holds the authority to close trials due to safety concerns. PRMS-related activities are managed via a centralized, uniform process using a REDCap-based PRMS Dashboard. MCCCC PRMS is governed by the PRMS Executive Committee, with direct reporting though the PRMS Chair to the MCCCC Clinical Research Leadership Committee, chaired by the Enterprise Deputy Director for Clinical Research. PRMS underwent a transformational reorganization beginning in 2023, including implementing a revised cancer-related clinical trial definition, streamlining the organizational structure and operations, and improving data capture and dashboards. As a result of reorganization and streamlining, the time from protocol submission to decision in Stage 2 decreased from 22 to 14 days in just one year. The implementation of a revised Low Accrual Policy and corresponding Rare Disease Policy enabled PRMS to take more deliberate, objective action on underperforming trials and led to the closure of 28 trials in 2023 making up 67% of all PRMS closures from 2018-2023.