Protocol Review and Monitoring System

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PROJECT SUMMARY/ABSTRACT The Markey Cancer Center's (MCC) clinical research mission is to conduct the highest quality research into the causes and treatment of cancer. In accordance with the CCSG guidelines for National Cancer Institute- designated Cancer Centers, MCC has established appropriate mechanisms for assuring rigorous scientific scrutiny and oversight of cancer-relevant clinical trials through the Protocol Review and Monitoring System (PRMS). The MCC Protocol Review and Monitoring Committee (PRMC) is responsible for independent peer review of scientific merit, feasibility, and prioritization of new protocols, and monitoring all trials for scientific progress and accrual (including termination of studies not meeting MCC scientific goals). Protocols are submitted to the PRMC following review by disease groups, called Clinical Care and Research Teams (CCARTs), for fit with the portfolio and endorsement by investigators, and review by the Feasibility Review Committee (FRC) for operational feasibility. The goal of prior review and input by the CCARTs and FRC is to enrich the scientific quality and prioritization of protocols submitted to the PRMC. The PRMC ensures that all interventional cancer research studies involving human subjects conducted under the auspices of the MCC: 1) serve and support the mission of MCC including prioritization of research trials relevant to catchment area needs; 2) have high scientific merit; 3) are statistically sound and appropriately designed; 4) are feasible for timely completion based on the available patient population and in the context of the current trial portfolio; 5) are prioritized, based on MCC criteria and in light of actively accruing trials; and 6) are inclusive of underserved populations (e.g., women, minorities, children). After activation, protocols are monitored by the PRMC for ongoing scientific progress and accrual per MCC policy. The PRMC has ultimate authority to suspend or close protocols for low accrual or significant change in scientific merit, and the responsibility for continuous monitoring of its efficiency and quality in the timely review of trials. During this funding period, the PRMS has undergone significant improvement in procedures and policy updates. Specifically, the PRMS enhanced scientific rigor of its review process by increasing senior reviewers, standardizing review criteria and scoring, and adopting more stringent accrual monitoring practices The PRMS has a new Chair and Co-chair free from conflicts of interest with the other clinical research bodies, and the PRMC members now comprises mainly senior faculty and a greater diversity of scientific disciplines. From 2013 to 2016, the PRMC reviewed and/or prioritized 284 new protocols, of which 264 (93%) were approved and 20 (7%) were disapproved; and reviewed 279 active protocols for scientific progress, closing 37 protocols due to low accrual or a change in scientific merit. As the MCC grows, the PRMS will continue rigorous scientific review of protocols, appropriate prioritization, adherence to MCC's mission, and inclusion of trials with a scientific focus relevant to the catchment area of Kentucky.