Protocol Review and Monitoring System

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PROJECT SUMMARY: Protocol Review and Monitoring System Shivaani Kummar, M.D., Associate Director of Clinical and Translational Research The Knight Cancer Institute (KCI) Protocol Review and Monitoring System (PRMS) supports the development of a comprehensive and scientifically relevant portfolio of clinical trials. The PRMS ensures that cancer patients have access to clinical trials that are scientifically sound in design, feasible for timely completion, compliant with federal guidelines, deserving of priority, and in alignment with the strategic goals of the institute. There are two distinct stages of scientific review for all clinical trials. The first stage comprises the Clinical Research Disease Site Group (DSG), and the second stage is the KCI PRMS Committee. Proposed trials undergo an initial review by the DSG to assess scientific merit, alignment with the KCI and disease site goals, available resources including relevant patient population, feasibility for completion within the specified timeframe, competing trials, and fit within a disease-level portfolio. In the second stage of the process, the PRMS reviews for the relevance of the scientific question, soundness of the design, feasibility to conduct the trial, and ability of the trial to meet an unmet need within the disease trial portfolio. Eligible protocols undergo a formal scientific progress evaluation twice yearly to monitor accrual against the target with appropriate corrective actions for protocols that fail to meet accrual targets. In addition, scientific relevance is re-evaluated for trials open to accrual beyond five years. The PRMS has full authority to enact the scientific progress evaluation determination. Personnel in the KCI Clinical Research Quality and Administration group provide administrative support for the PRMS Committee, which acts independently of the OHSU Institutional Review Board (IRB) and the KCI Data and Safety Monitoring Committee (DSMC).