PROTOCOL REVIEW AND MONITORING SYSTEM ABSTRACT The Knight Cancer Institute Protocol Review and Monitoring System (PRMS) supports the development of a broad and scientifically relevant portfolio of clinical trials. The PRMS works to ensure that cancer patients have access to clinical trials that are rigorous in design, feasible for timely completion, compliant with federal guidelines, deserving of priority, and congruent with the strategic goals of the institute. Two distinct, but critical leadership entities oversee the process: Clinical Research Disease Site Leaders (DSLs) and the Knight PRMS committee. Proposed trials undergo initial prioritization by a DSL to assess scientific merit, alignment with the Institute and disease site goals, available resources, feasibility for completion within specified timeframe, and fit within a disease-level portfolio. In the second-step of the process, the PRMS reviews for 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 receive a twice yearly scientific progress evaluation by the PRMS to ensure accrual is on target. In addition, scientific relevance is evaluated for trials open to accrual beyond 5 years. The PRMS has full authority to enact the scientific progress evaluation determination. Personnel in the Knight Clinical Research Quality and Administration group provide administrative support for PRMS, which acts independent of the OHSU Institutional Review Board (IRB) and the Knight Data and Safety Monitoring Committee (DSMC).
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