The Protocol Review and Monitoring System (PRMS) for the NYUCI is responsible for evaluating the scientific merit of all cancer-related population-based, translational and clinical research studies that take place on the NYU Langone Medical Center campus and those of its strategic alliances. Once the clinical protocol documentation has been completed, the PRMS provides a forum for multi-level review, confirming the scientific merit and programmatic fit. After the NYU School of Medicine Institutional Review Board (IRB) approves the protocol, the PRMS monitors for scientific progress and performance. A central core of the PRMS is the Protocol Review and Monitoring Committee (PRMC). PRMC membership is drawn from the membership of the NYUCI based on expertise in the development and conduct of clinical trials, as well as leadership in key clinical positions. Physician members of the committee represent the different subspecialties providing care and participating in clinical research within the NYUCI. In addition, the PRMC includes bench scientists, biostatisticians, members of the administrative staff of the NYUCI, oncology nursing and the investigational pharmacy. PRMC approval is required for IRB submission and approval. PRMC review includes the underlying hypothesis, design, and the likelihood that the trial will lead to clinically meaningful results. The PRMC monitors accrual yearly and requires that investigators provide a formal plan to increase enrollment if accrual is <50% of projected target. The PRMC has the authority to close under-accruing 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. The number of reviewed protocols has increases since the last review. In 2011, PRMC reviewed 126 protocols as compared to 94 in 2007.
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