Protocol Review and Monitoring Committee

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The Moores Cancer Center (MCC) Protocol Review and Monitoring System (PRMS) oversees and provides independent, peer review of the scientific merit, priority, and progress of all cancer studies involving human subjects conducted at the University of California, San Diego, its affiliated Rady Children's Hospital as well as cancer-related population sciences research conducted at MCC's consortium partner, San Diego State University. PRMS functions are accomplished by rigorous review in a 2-stage process conducted by: 1) MCC multidisciplinary Disease Teams, where initial assessment of value, fit, and prioritization within the existing portfolio of studies is performed as well as an assessment of each study's operational and accrual feasibility; and 2) the Protocol Review and Monitoring Committee (PRMC), which is the definitive independent authority for determining which studies proceed to activation. The Disease Teams' input and approval are required before proceeding to the PRMC; however, only the PRMC has final and independent authority with regards to determining which studies will be activated and which underperforming studies will be closed. The PRMC has the primary goal to ensure that all MCC-aligned cancer research studies involving human subjects are: 1) scientifically sound; 2) effectively designed, specifically from a biostatistics perspective; 3) appropriately prioritized within MCC's Disease Teams' research portfolios to avoid competing trials as well as aligned with MCC's overall institutional priorities for clinical research; 4) feasible for completion or in meeting institutional accrual goals; 5) assessed for the adequacy of the data and safety monitoring plans based on the risk level of the study; and 6) monitored regularly for accrual and scientific progress. In 2017, the MCC Disease Teams have vetted in aggregate 198 studies and forwarded 165 of these studies to PRMC review. Once received by the PRMC, 46 of these studies received an initial expedited review by the PRMC Chair, Vice Chair, or a PRMC designee as they had already received an appropriate external scientific peer-review, and 119 of these studies, primarily representing MCC's investigator-initiated and industry-sponsored trials, were forwarded for full PRMC review. More than 22% of the studies reviewed by the PRMC required modifications prior to being approved, and 3 studies were disapproved and not allowed to proceed through the activation process. In addition, the PRMC also conducted scientific and accrual progress reviews for all actively accruing MCC studies for which 24 underperforming studies were closed in 2017. The MCC PRMS, inclusive of the Disease Team and PRMC review processes, is one of the most critical functions that the MCC performs to ensure the highest quality of research is being conducted at MCC.