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) 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, with Stage One involving Disease Groups (DGs) and a Feasibility Review Committee (FRC) and Stage Two involving the Protocol Review and Monitoring Committee (PRMC) for a separate, independent review. PRMS coordinators support investigators and committee members in navigating the two required stages of review for all applicable studies. Studies approved by the PRMC are monitored throughout the lifecycle of the study. Independent Disease Groups (DGs) review new concepts and protocols to assess scientific merit, availability of the relevant patient population, overlap with potentially competing trials, and whether protocols align with and advance DG- and SCC-based goals. DGs assign a priority score to each study utilizing a Prioritization Schema that reflects the overall research priorities of the SCC. This discussion tool guides the evaluation of new protocols to assess the availability of patients and estimate the number of local patients anticipated based on SCC’s patient population. In 2021, DGs reviewed 286 new protocols; 126 (44%) were not approved to continue to the PRMC. The SCC’s PRMC is chaired by Adam Asch, MD (CT) and co-chaired by Melissa Craft, BSN, MS CNS, PhD (CPC affiliate). PRMC membership includes broad representation from multiple disciplines engaged in cancer clinical research. Its 18 voting members are selected based on their disciplinary-specific knowledge, experience in design and conduct of 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 2021, the PRMC reviewed 145 new protocols (128 approved, 9 approved with revision, 4 tabled and 4 disapproved). The PRMC also monitors active protocols annually for ongoing accrual and has the authority to close protocols that do not demonstrate adequate scientific progress. In 2021, the PRMC reviewed 514 active protocols for accrual progress. Of these, 335 were approved to continue, 168 were required to submit Accrual Enhancement Plans, and 11 were closed.