Protocol Review and Monitoring

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The Protocol Review and Monitoring System (PRMS) for the NYUCI is responsible for evaluating the scientific merit of all cancer-related translational and clinical research studies that take place on the NYU Medical Center campus and those of its affiliates. Once the clinical protocol documentation has been ' completed, the PRMS provides a forum for multi-level review, confirming the scientific merit and programmatic fit, as well as assuring allocation of appropriate research resources. After the NYU School of Medicine Institutional Review Board (IRB) approves the protocol the PRMS provides ongoing oversight of the research activity and the ability of the study to meet research objectives. A central core of the PRMS is the Protocol Review and Monitoring Committee (PRMC). The PRMC membership is drawn from the membership of the NYUCI based on expertise in clinical trial development and conduct of clinical trials, as well as leadership in key clinical positions. Physician members of the Committee represent the different subspecialties who provide care and participate in clinical research within the NYUCI. In addition the PRMS includes bench scientists, biostatisticians, members of the administrative staff of the NYUCI, oncology nursing and the investigational pharmacy. Protocols must be approved by the PRMC before submission to the NYU Institutional Review Board. The PRMC review includes the underlying hypothesis, design, and the likelihood that the trial will lead to clinically meaningful results. The Committee has the added duty to examine and evaluate the priority of the planned research in the context of programmatic aims and the resources available. The PRMC monitors accrual yearly and requires that investigators provide a formal plan to increase enrollment if accrual is < 50% of projected. The PRMC has the authority to close underaccruing trials. Investigator initiated studies are the highest priority for the NYUCI especially those involving novel agents based on laboratory results from NYUCI basic and/or translational scientists. A fifty increase in trials submitted to the PRMC has occurred during the last funding cycle due to the emphasis on clinical research by Senior Leadership.