NABTC Central Operation Grant (UCSF Project Leader)

NABTC 中央运营补助金（UCSF 项目负责人）

• 批准号: 6952770
• 负责人: MICHAEL D PRADOS
• 金额: $ 38.9万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-03-25 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6952770
• 关键词: brain neoplasms; clinical research; computer data analysis; cooperative study; data management; health science research support; human data; statistics /biometry

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.

描述（由申请人提供）：北美脑肿瘤协会（NABTC）成立于1993年，一直为恶性脑肿瘤患者进行早期临床试验。NABTC的中央运作办公室/协调中心位于加州大学旧金山分校（UCSF），由Michael Prados博士领导。UCSF中央运作办公室/协调中心将继续协调参与NABTC的成员机构和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神经肿瘤学分会的一个非资助成员机构和德克萨斯大学圣安东尼奥分校的1个药代动力学中心组成。NABTC将与癌症治疗部门的癌症治疗评估项目（CTEP）和放射研究项目（RRP）协调工作，在该患者群体中开展新疗法。中央业务办公室/协调中心将提供行政管理、方案制定和提交协调、研究实施、质量控制、方案绩效监测、统计分析、遵守NCI药品责任要求、FDA、OHRP和HHS法规，以及方案和机构绩效报告。作为小组组长，普拉多斯博士将在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的数据管理将继续由MD安德森癌症中心数据管理中心的分包合同提供支持。NABTC中央运营办公室/协调中心的目标是确保正在进行的和新的新颖临床试验期间的高质量研究，并对中枢神经系统肿瘤生物学方面具有潜在临床意义的辅助实验室研究。在此更新申请中，NABTC还将计划与其他资助的成人（NABTT）和儿科（PBTC）脑肿瘤联盟、人类癌症小鼠模型联盟、最近资助的脑肿瘤孢子机构（UCSF和阿拉巴马大学）以及NIH/NCI的内部神经肿瘤学分支进行互动。NABTC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，在过去的9年里合作良好，在过去的5年里积累了近1000名患者进行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，并有望提高患者群体的总生存率。