NABTC Central Operation Grant (UCSF Project Leader)

描述（由申请人提供）：北美脑肿瘤联盟（NABTC）成立于1993年，并持续对恶性脑肿瘤患者进行早期临床试验。NABTC的中央运营办公室/协调中心位于加州圣弗朗西斯科大学（UCSF），由医学博士Michael Prados领导。UCSF中央运营办公室/协调中心将继续协调参与成员机构和NABTC药代动力学中心的科学和行政活动。NABTC将由来自美国各地的7个正式成员机构、NCI/NINDS神经肿瘤学分支的一个非资助成员机构和德克萨斯大学圣安东尼奥的一个药代动力学中心组成。NABTC将与癌症治疗部的癌症治疗评估计划（CTEP）和放射研究计划（RRP）协调努力，在这一患者群体中进行新的治疗。中央运营办公室/协调中心将提供行政管理、方案制定和提交的协调、研究实施、质量控制、方案性能监测、统计分析、遵守NCI药物清点、FDA、OHRP和HHS法规以及方案和机构性能报告的要求。作为组长，Prados博士将在CTEP的协助下监督NABTC的科学、临床和行政活动，以实现NABTC的目标。NABTC的数据管理将继续得到MD安德森癌症中心数据管理中心的分包合同的支持。NABTC中央运营办公室/协调中心的目标是在正在进行的和新的临床试验期间确保高质量的研究，并对具有潜在临床意义的CNS肿瘤生物学方面进行辅助实验室研究。在这次更新申请中，NABTC还计划与其他受资助的成人（NABTT）和儿童（PBTC）脑肿瘤联盟，人类癌症联盟的小鼠模型，最近资助的脑肿瘤孢子机构（UCSF和亚拉巴马大学）以及NIH/NCI的内部神经肿瘤学分支进行互动。在中央运营办公室/协调中心、其成员机构和药代动力学中心的协助下，NABTC在过去9年中合作良好，在过去5年中有近1000例患者参与了I期和早期II期研究，并寻求在未来5年进一步加强这一努力。NABTC将使用新型治疗药物治疗患者，最终目标是提高质量，并有望提高该患者人群的总生存率。

DESCRIPTION (provided by applicant): The North American Brain Tumor Consortium (NABTC) was formed in 1993 and has continuously conducted early phase clinical trials for patients with malignant brain tumors. The Central Operations Office/Coordinating Center for the NABTC is at the University of California San Francisco (UCSF) under the Group Leadership of Michael Prados, MD. The UCSF Central Operations Office/Coordinating Center for this renewal grant application will continue to coordinate the scientific and administrative activities of the Participating Member Institutions and Pharmacokinetics Center of the NABTC. The NABTC will be composed of 7 full Member Institutions from across the United States, a non-funded Member Institution at the NCI/NINDS Neuro-Oncology Branch, and 1 Pharmacokinetics Center at the University of Texas San Antonio. 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 Central Operations Office/Coordinating Center will provide administrative management, coordination of protocol development and submissions, study conduct, quality control, protocol performance monitoring, statistical analysis, adherence to requirements regarding NCI drug accountability, FDA, OHRP and HHS regulations, and protocol and institutional performance reporting. As Group Leader, Dr. Prados will oversee the scientific, clinical and administrative activities of the NABTC, with the assistance of CTEP, in order to achieve the NABTC goals. Data Management for the NABTC will continue to be supported by a subcontract with the MD Anderson Cancer Center Data Management Center. The goal of the NABTC Central Operations Office/Coordinating Center will be to assure high quality research during the conduct of ongoing and new novel clinical trials and to perform ancillary laboratory investigations of aspects of CNS tumor biology with potential clinical implications. In this renewal application, the NABTC will also plan to interact with the other funded adult (NABTT) and pediatric (PBTC) brain tumor consortia, the Mouse Models of Human Cancer Consortium, the recently funded Brain Tumor SPORE institutions (UCSF and University of Alabama), and the intramural Neuro-Oncology Branch at the NIH/NCI. The NABTC, with the assistance of the Central Operations Office/Coordinating Center, its Member Institutions and Pharmacokinetics Center, has worked well together over the last 9 years, accruing nearly 1000 patients to phase I and early phase II studies in the last 5 years, and seeks to further enhance this effort in the next 5 years. The NABTC will treat patients using novel therapeutic agents with the ultimate goal to increase quality, and hopefully, overall survival in this patient population.