The Protocol Review and Monitoring System (PRMS) for the NYUCI is responsible for evaluating thescientific merit of all cancer-related translational and clinical research studies that take place on the NYUMedical 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 andprogrammatic fit, as well as assuring allocation of appropriate research resources. After the NYU School ofMedicine Institutional Review Board (IRB) approves the protocol the PRMS provides ongoing oversight ofthe research activity and the ability of the study to meet research objectives. A central core of the PRMS isthe Protocol Review and Monitoring Committee (PRMC). The PRMC membership is drawn from themembership of the NYUCI based on expertise in clinical trial development and conduct of clinical trials, aswell as leadership in key clinical positions. Physician members of the Committee represent the different subspecialtieswho provide care and participate in clinical research within the NYUCI. In addition the PRMSincludes bench scientists, biostatisticians, members of the administrative staff of the NYUCI, oncologynursing and the investigational pharmacy. Protocols must be approved by the PRMC before submission tothe NYU Institutional Review Board. The PRMC review includes the underlying hypothesis, design, and thelikelihood that the trial will lead to clinically meaningful results. The Committee has the added duty toexamine and evaluate the priority of the planned research in the context of programmatic aims and theresources available. The PRMC monitors accrual yearly and requires that investigators provide a formalplan to increase enrollment if accrual is < 50% of projected. The PRMC has the authority to close underaccruingtrials. Investigator initiated studies are the highest priority for the NYUCI especially those involvingnovel agents based on laboratory results from NYUCI basic and/or translational scientists. A fifty increase intrials submitted to the PRMC has occurred during the last funding cycle due to the emphasis on clinicalresearch by Senior Leadership.
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