Protocol Review and Monitoring System

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ABSTRACT – PROTOCOL REVIEW AND MONITORING SYSTEM Duke Cancer Institute’s Protocol Review and Monitoring System (PRMS) falls within the scope of responsibility of the Cancer Protocol Committee (CPC). The CPC is responsible for implementation of the PRMS function, including evaluating the scientific merit and progress of all studies that meet the DCI definition of “cancer-related”. While the CPC upholds standards in scientific rigor and integrity during the protocol review process, it also helps investigators and study teams attain such standards by providing essential resources and education. By meeting its scientific oversight responsibilities, the CPC ensures that DCI investigators conduct high quality and impactful clinical research that aligns with the DCI’s research priorities and meets the needs of the cancer patient community. In addition, the CPC works closely with the clinical Disease Groups and DCI CCSG Research Programs in the prioritization of clinical trials for review. The CPC is a scientific peer-review committee comprised of 40 voting members that reflect the multidisciplinary clinical research enterprise at the DCI. The CPC membership is selected to ensure diverse expertise relevant to cancer clinical research and is composed of clinical investigators, investigational pharmacists, biostatisticians, translational PhD scientists, and patient advocates. All cancer-related protocols are approved by the CPC prior to activation and approved studies that remain open to enrollment must undergo continuing review by the CPC every six months from study activation. Studies reviewed include interventional (treatment, preventive, supportive, diagnostic) and non-interventional (ancillary, correlative [tissue-based], observational) studies. In addition, amendments to cancer-related studies are prospectively assessed and reviewed by the CPC. The CPC approves well-designed studies that hold the potential to positively affect cancer care and has the authority to terminate studies that fail to demonstrate meaningful progress or lose relevance due to shifting paradigms of cancer research and cancer patient care. During the past project period, CPC reviewed a total of 1,316 new protocols, 918 annual renewals, and 322 amendments.