PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) ABSTRACT The objective of the Protocol Review and Monitoring System (PRMS) of the UAB CCC is to assure that the interventional (therapeutic and non-therapeutic) protocols for cancer have scientific merit, that they meet the priorities of the UAB CCC, and that they progress to scientifically meaningful results. The PRMS is made up of the Disease Working Groups (DWG), the Protocol Review Committee (PRC) and the Clinical Trial Operations Committee (CTOC). The PRMS's responsibilities include the scientific review and prioritization of all interventional protocols (clinical trials). The PRMS utilizes a three-tier review process whereby all interventional protocols are assessed by the appropriate DWG for merit and prioritization and, upon approval, are submitted to the CTOC. The CTOC reviews letters of intent for compliance with CCC priority guidelines, feasibility, and infrastructure capacity. Upon CTOC approval protocols are submitted to the PRC. The PRC then undertakes a detailed scientific review and makes final decisions for approval, approval with minor modifications, deferral for major modifications, or disapproval. The PRC is composed of Cancer Center Associate Director for Clinical Research and selected members representing expertise of the various oncology disciplines, laboratory research, basic science, cancer control/prevention, radiology, biostatistics, and research nursing. Written evaluation and recommendations of the committee accompany IRB applications on protocols approved by the PRC. The CTOC also reviews all active protocols monthly in regard to patient accrual and progress and has the authority to terminate any protocol that is not progressing. During the current funding period, the PRMS has provided initial review and/or prioritization of 318 protocols with 277 (87.1%) receiving approval (with or without minor revision) and 41 (12.9%) failing to receive approval including 36 (11.3%) receiving deferral and 5 (1.6%) receiving disapproval. Of the 36 protocols receiving deferral, 35 were granted approval on resubmission. The PRMS also provided administrative prioritization of 66 national cooperative group trials with Disease Working Group support and recommendations. Over the past funding period, the PRMS provided annual review for accrual and progress of 208 active protocols. In the 2014 review for accrual and progress, the CTOC considered 108 protocols and identified 39 underperforming trials. Of those, 27 received a 12-month approval for their action plans and 12 protocols were placed on probation. Subsequently eight of those twelve were closed to accrual. The PRMS will continue rigorous review of Cancer Center protocols for scientific quality and Cancer Center priority as well as monitoring of accrual and progress of active protocols.
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