NABTC CENTRAL OPERATION GRANT (UCSF PROJECT LEADER)

描述：（申请人的描述） 中央业务办公室/协调中心为这一赠款申请 是协调北方活动的行政单位 美国脑肿瘤联盟（NABTC）成立的目的是进行 成人患者的实验室和临床I期和II期研究试验 患有恶性脑瘤 NABTC将由七种治疗方法组成 中心和1个药代动力学中心，并将保持合作NABTC 组织库 NABTC将与癌症治疗中心协调其工作， 评估计划（CTEP）和辐射研究计划（RRP） 癌症治疗部在该患者中进行新疗法 人口 NABTC的领导机构是University of 加州，旧金山弗朗西斯科（UCSF），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礼宾司的工作。 文件和提交、研究实施、质量控制、方案 性能监测、统计分析、遵守要求 关于NCI药物清点、FDA、OPRR和HHS法规，以及 议定书和机构业绩报告。 普拉多斯博士将是 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。 部分这些 这些活动将在MD安德森的指导下完成 癌症中心数据管理和统计中心，一个运营中心 它在参与中保持了一个经过审查的领导作用， 联合体和团体间研究。 本次NABTC Central的最终结果 业务处将确保质量，可验证，协调 研究数据将允许正在进行的快速II期试验和实验室 调查将以最有效的方式进行， 到目前为止，患者的生存机会很小。

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.