Protocol Review and Monitoring System

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PROTOCOL REVIEW AND MONITORING SYSTEM – ABSTRACT The Protocol Review and Monitoring System (PRMS) oversees all cancer-related clinical research at the Stephenson Cancer Center (SCC), including clinical research at the Oklahoma Medical Research Foundation (the SCC's proposed consortium partner), in order to ensure that it is of the highest scientific merit, adheres to the strategic priorities of the SCC, demonstrates ongoing progress and efficiently utilizes SCC resources. The PRMS conducts protocol review in a two-stage process. In stage one, Multidisciplinary Disease-Site Committees (MDCs) initiate and/or review protocols (when disease-based) proposed by member investigators in order to assess scientific merit, availability of relevant patient population, overlap with potentially competing trials and whether protocols align with disease-site program goals. The MDC also assists investigators in the development of investigator-initiated trials (IITs). The SCC's Budget and Operations Committee (BOC), which is comprised of the leadership of the Clinical Trials Office (CTO) and SCC Administrative Core, reviews all new institutional protocols to ensure effective CTO resource utilization, operational feasibility and appropriateness of cost allocation. In stage two, the Protocol Review and Monitoring Committee (PRMC) conducts an independent review of the protocol to assess scientific merit and design feasibility. The SCC Director has delegated to the PRMC the institutional authority to open protocols that meet SCC standards for scientific merit and scientific priorities and to terminate protocols that do not demonstrate scientific progress. PRMC membership includes broad representation from multiple disciplines engaged in cancer clinical research. Its 21 voting members are selected based on their disciplinary-specific knowledge, experience in designing and conducting research studies, and/or specialized clinical expertise. Depending on trial type, the PRMC performs either an expedited Administrative Review or Full Committee Review. If the latter, at least two reviewers from the PRMC voting members are assigned to the protocol. A protocol is approved with a majority vote of a quorum of members. PRMC review occurs prior to submission to the Institutional Review Board (IRB), and per institutional policy the latter will not review cancer-related protocols until approved by the PRMC. In 2016, the PRMC reviewed 114 new protocols. The PRMC also monitors active protocols annually for ongoing accrual and has the authority to close protocols that do not demonstrate adequate scientific progress. A focused process designed to enhance accrual to low enrolling trials is also part of the PRMC. In 2016, the PRMC reviewed 73 active protocols for accrual progress. Of these, 41 were approved to continue, 27 were required to submit Accrual Enhancement Plans, and five were closed due to low accrual.