) The Central Operations Office/Coordinating Center for this grant application is the administrative unit that will coordinate the activities of the North American Brain Tumor Consortium (NABTC) formed for the purpose of conducting laboratory and clinical Phase I and II research trials for adult patients with malignant brain tumors. The NABTC will be composed of seven treatment centers and 1 pharmacokinetics center, and will maintain a cooperative NABTC tissue bank. The NABTC will coordinate its efforts with the Cancer Therapy Evaluations Program (CTEP) and the Radiation Research Program (RRP) of the Division of Cancer Therapy to conduct novel therapies in this patient population. The Lead Institution of the NABTC is the University of California, San Francisco (UCSF), and the Project Leader is Michael Prados, MD. The Central Operations Office will provide coordination of protocol d e velopment and submissions, study conduct, quality control, protocol performance monitoring, statistical analysis, adherence to requirements regarding NCI drug accountability, FDA, OPRR and HHS regulations, and protocol and institutional performance reporting. Dr Prados will be the Principal Investigator of the Central Operations Office and thus will coordinate the clinical and administrative actives of the NABTC in order to achieve the NABTC goals with the assistance of CTEP. Part of these activities will be accomplished with a subcontract with the MD Anderson Cancer Center Data Management and Statistical Center, an operations center that has maintained a p e er-reviewed leadership role in its participation in consortium and intergroup studies. The end results of this NABTC Central Operations Office will be to assure quality, verifyable, coordinated research data that will allow ongoing rapid Phase II trials and laboratory investigations to be conducted in the most efficient manner possible in a patient population that thus far has little chance for survival.
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