Protocol Review and Monitoring System

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PROJECT SUMMARY/ABSTRACT In accordance with CCSG guidelines, the Markey Cancer Center (MCC) has established appropriate mechanisms for ensuring rigorous scientific oversight of cancer clinical trials through the Protocol Review and Monitoring System (PRMS). Protocols undergo initial scientific review by Clinical Care and Research Teams (CCARTs), including assessment of relevance to the patient population, fit within the portfolio and interest of investigators. In 2019, the MCC formalized first-stage review by CCARTs, expanding structure and function, and enhancing communication with the Protocol Review and Monitoring Committee (PRMC). Following CCART approval, review for operational feasibility is completed by the Feasibility Review Committee. The goal of these reviews is to ensure that only the highest quality trials are submitted to the PRMC. The MCC PRMC is responsible for independent peer-review of scientific merit, feasibility and prioritization of new protocols. Following activation, PRMC monitors protocols for ongoing scientific progress and has ultimate authority to suspend or close protocols that do not meet MCC scientific standards. The Specific Aims of the PRMS are: 1) Optimize the PRMS structure and process for sufficient size and breadth of expertise to conduct a critical, rigorous and fair scientific review of all institutional cancer-related research protocols involving human subjects; 2) Ensure that clinical trials conducted at MCC support and enable the scientific mission of the center, are relevant to patients in the catchment area, including those from underserved groups, and enhance the inclusion of diverse populations; 3) Safeguard the scientific integrity, feasibility and prioritization of all cancer- related interventional clinical research of the MCC and apply rigorous scientific review criteria in a consistent and objective manner; 4) Oversee the progress and performance of all interventional cancer clinical trials to ensure their continued scientific merit and accomplishment of the scientific goals of the protocol and the MCC. Highlights during the funding period include incorporation of first-stage reviews into PRMS framework, enhanced member education, expanded representation in key scientific areas and strengthened quorum expectations. From 2019 to 2021, the CCARTs reviewed 409 clinical trials for potential opening, approved 294 (72%) and declined 115 (28%); the Feasibility Review Committee declined 20 (4%) due to lack of feasibility. From 2019 to 2021, the PRMC reviewed and/or prioritized 239 new protocols, of which 230 were approved and 9 were disapproved. In the past three years, the PRMC reviewed 552 active protocols for scientific progress, closing 29 protocols due to low accrual or a change in scientific merit. The PRMC continuously assesses its own performance. In 2021, median time from PRMC submission to approval was 8 days overall (7 national, 8 industry, 24 institutional). As the MCC has matured, the PRMS has continued to optimize the first- and second- stage review and to increase scientific rigor, objectivity and scrutiny of each trial’s relevance to our diverse population in order to ensure MCC brings the highest quality clinical research to Kentuckians.