CLINICAL TRIALS - PROTOCOL REVIEW MONITORING SYSTEM

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The Protocol Review and Monitoring System of the Winship Cancer Institute Clinical Trials Office (WCI CTO) is a Shared Resource that supports clinical research by providing scientific review, prioritization and monitoring of clinical trials involving cancer patients. The long-term goal of the WCI PRMS is to advance progress in cancer care by ensuring the highest scientific quality of clinical research involving cancer patients at the WCI. The specific objectives for the PRMS are as follows: 1) To review new proposals for clinical research to ensure that they are scientifically meritorious, that they address significant clinical issues, and that there are sufficient patient and institutional resources to conduct the study as proposed. 2) To prioritize proposed clinical research across disease sites in order to meet the objectives of the WCI Programs and the overall goal of completing high-quality, high-impact clinical research involving cancer patients. 3) To review the scientific progress of existing clinical research protocols, and to terminate protocols in which accrual rates are inconsistent with meeting the stated scientific objective or in which new scientific data renders the trial unsafe or unimportant. 4) To monitor the accuracy and timeliness of scientific data obtained during the conduct of clinical studies. The WCI PRMS is supported by the WCI Clinical Trials Office and includes the Clinical and Translational Research Committee (CTRC) chaired by Tom Olson (Chairman) and Tom Heffner (Vice-Chairman), two experienced clinical investigators. The CTRC includes representation from basic science, clinical research, bio-statistics, pharmacology, and behavioral science. The CTRC maintains the scientific integrity of clinical research conducted through the WCI CTO by ensuring that the scientific question being addressed is significant, that the study will yield new information relevant to the cancer problem, and that the conduct of the study, including accrual rates, is sufficient to answer the scientific question that it is addressing. The accuracy and timeliness of clinical and laboratory data generated by clinical protocols is monitored by the Data, Safety, and Monitoring Committee (DSMC) that is part of the Data, Safety, and Monitoring Plan of the WCI CTO. Any major irregularities in the accuracy or timeliness of clinical data are reported to the WCI Medical Director and reviewed by the CTRC. The Cancer Institute Director, the Medical Director of the WCI CTO and the chairmen of the Working Groups receive monthly reports of accrual of subjects onto therapeutic studies for review.