Protocol Review and Monitoring System (PRMS)

University Of Arizona, Tucson AZ

Investigators

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Abstract

PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT The University of Arizona Cancer Center (UACC) 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 Arizona (UA). The Scientific Review Committee (SRC) is the principal functional component of PRMS and has final and independent authority with regard to determining which studies will be activated and when studies will be closed. It is a multidisciplinary committee that includes oncologists, cancer prevention specialists, basic and population scientists, therapeutic development specialists, biostatisticians, and others, that reflects the breadth of UACC research. The PRMS is a two-step process. First, the Clinical Research Teams (CRTs) assess the value, fit, and prioritization within the existing portfolio of studies, as well as an assessment of each study’s feasibility, regarding both conduct and accrual. In the second step, the Scientific Review Committee (SRC) provides peer review and feedback, ultimately determining, based on scientific merit, whether the study should proceed. The SRC has the primary goal of ensuring that all cancer-relevant research studies involving human subjects at UA are: 1) scientifically sound; 2) statistically valid; 3) appropriately prioritized and without redundancy. The SRC also reviews the data and safety monitoring plans to assure that they are consistent with the risk level of the study. In 2020, the CRTs vetted 213 studies and forwarded 113 (4 were from Dec 2019) (51%) of these studies for SRC review. Of the studies reviewed by the SRC, 52 of studies received an expedited review due to having already undergone an external scientific peer review. These, predominantly, were NCTN trials. The other 60 trials underwent full committee review. Of all trials subject to full review, 109 were approved and 4 were disapproved. The SRC also conducted scientific and accrual progress reviews for all actively accruing UACC studies. In 2020, 85 trials were determined to be underperforming and given low accrual notices. Of these, 68 received warnings and were subject to near-term monitoring causing 20 to be administratively closed by the SRC and 44 to be closed by PI. The UACC PRMS mission is to ensure the highest quality of clinical research at the UACC.