NABTC CENTRAL OPERATION GRANT (UCSF PROJECT LEADER)

描述：(申请人描述) 本次拨款申请的中央业务办公室/协调中心 是协调北方活动的行政单位 美国脑瘤联合会(NABTC)成立的目的是进行 成人患者的实验室和临床I、II期研究试验 患有恶性脑瘤。NABTC将由七个治疗方案组成 中心和1个药代动力学中心，并将维持一个合作的NABTC 组织银行。NABTC将协调其与癌症治疗的努力 评估计划(CTEP)和辐射研究计划(RRP) 癌症治疗部门将为这位患者进行新的治疗 人口。NABTC的牵头机构是加州大学 加州旧金山(加州大学旧金山分校)，项目负责人是迈克尔·普拉多斯， 马里兰州中央业务办公室将协调《议定书》。 发展和提交、研究进行、质量控制、方案 性能监控、统计分析、遵守要求 关于NCI药品责任、FDA、OPRR和HHS法规，以及 礼宾和机构业绩报告。普拉多斯博士将成为 中央行动办公室首席调查员，因此将 协调NABTC的临床和行政活动，以便 在CTEP的协助下实现NABTC的目标。其中一部分 活动将通过与MD Anderson的分包合同来完成 癌症中心数据管理和统计中心，运营中心 在其参与过程中保持了经过审查的领导作用 在联合体和小组间研究中。本次NABTC Central的最终结果 运营办公室将确保质量，可核查，可协调 研究数据将允许正在进行的快速第二阶段试验和实验室 调查应尽可能以最有效的方式进行 到目前为止生存机会微乎其微的患者群体。

DESCRIPTION: (Applicant's Description) 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.