Core 2: Biostatistical and Clinical Core

项目摘要/摘要 生物统计和临床核心将提供支持所有三种孢子研究所需的专业知识 项目以及发展研究和职业提升项目。生物统计学的整合 这一核心中的临床研究团队确保在规划阶段和 允许在计划的分析和实验中进行调整。单个共享核心将提高性能 监督孢子驱动的项目和临床试验，并确保工作协调一致，具有成本效益。《核心》 领导者有相当丰富的综合经验来管理在设计和实施中出现的挑战 脑肿瘤的临床研究，包括分子亚型、神经影像终点、脑肿瘤的相关知识。 治疗肿瘤组织的收集和分析，以及毒性评估。生物统计学联合负责人是安妮特 Molinaro博士将与所有三个项目的个人领导人合作，评估统计和数据库 需要。她将就实验和临床研究的设计提供建议，包括 项目3的目标1；数据分析指导(通过在核心内执行分析或向合格人员提供建议 项目内人员)，包括使用适当的统计模型和适当的应用 统计检验；以及开发新的方法来帮助解释实验结果。在他的领导下， 在Molinaro的监督下，Core建成并将继续扩建和维护加州大学旧金山分校的脑瘤中心 数据库(Btcdb)。Btcdb将成为带注释的研究和临床的主要集中式存储库。 所有孢子调查人员使用的数据。这一独特且可定制的资源将连接临床信息 到孢子项目产生的成像、组织和基因组参数。临床联合负责人约翰·德 格罗特医学博士将在计划和进行临床研究以及评估结果方面与所有项目负责人互动 包括从#年人口科学研究中回顾血液免疫甲基组学的预后价值 项目1和评估新代谢成像研究在项目2患者中的效果。 格鲁特将在项目3中帮助开发和实施计划中的临床试验。核心将监督 所有临床研究，提供临床研究护士和数据协调员，并协助所需的监管 和合规报告。与项目3的临床合作者克拉克博士合作，德·格鲁特博士将促进 与血液学、血液和骨髓移植以及细胞治疗计划(HBC)和 加州大学旧金山分校、NCI和FDA的生命治疗倡议计划，以有效地激活和实施临床 审判。这个核心的主要目标是支持设计的项目的翻译研究 确定可靠的预后标志物；开发更准确地提供信息的非侵入性成像技术 关于治疗的早期反应和肿瘤负担；以及启动评估毒性的早期临床试验， 一种新型细胞疗法的药代动力学和药效学。该中心将提供统计和临床数据 对这些努力和发展方案的领导和投入。

Project Summary/Abstract The Biostatistical and Clinical Core will provide the expertise need to support the research of all three SPORE Projects and the Developmental Research and Career Enhancement projects. Integration of the biostatistical and clinical research teams in this Core ensures well-founded experimental designs in the planning phase and allows for adjustments in planned analyses and experiments. A single shared Core will improve the performance of SPORE-driven projects and clinical trials and ensure that the work is coordinated and cost-effective. The Core leaders have considerable combined experience managing challenges arising in the design and conduct of clinical studies for brain tumors including knowledge of molecular subtypes, neuroimaging endpoints, on- treatment tumor tissue collection and analysis, and toxicity assessments. The Biostatistics Co-leader is Annette Molinaro, Ph.D., will work with individual leaders from all three Projects to assess the statistical and database needs. She will provide advice on the design of experimental and clinical studies, including the clinical trial in Aim 1 of Project 3; data analysis guidance (either by performing the analyses within the core or advising qualified personnel within the projects), including the use of appropriate statistical models and appropriate applications of statistical tests; and the development of novel methods to help interpret results from experiments. Under Dr. Molinaro’s supervision, the Core built and will continue to expand and maintain the UCSF Brain Tumor Center Database (BTCDB). The BTCDB will be the primary, centralized repository for annotated research and clinical data used by all SPORE investigators. This unique and customizable resource will connect clinical information to imaging, tissue, and genomic parameters generated by the SPORE projects. The Clinical Co-leader, John de Groot, M.D., will interact with all Project leaders in planning and conducting clinical studies and assessing results including review of the prognostic value of blood immunomethylomics from the population science studies in Project 1 and evaluating the effect of novel metabolic imaging studies in patients in Project 2. Importantly, Dr. de Groot will be instrumental in developing and conducting a planned clinical trial in Project 3. The Core will oversee all clinical studies, provide clinical research nurses and data coordinators, and assist in the required regulatory and compliance reporting. Working with Dr. Clarke, the clinical co-PI for Project 3, Dr. de Groot will facilitate interactions with the Hematology, Blood and Marrow Transplantation, and Cellular Therapy program (HBC) and Living Therapeutics Initiative Program at UCSF, NCI, and FDA, to efficiently activate and conduct the clinical trial. The primary objective of this Core is to support the translational research of the Projects that are designed to identify robust prognostic markers; to develop non-invasive imaging techniques that inform more accurately on early response to therapy and tumor burden; and to activate an early phase clinical trial evaluating toxicity, pharmacokinetics, and pharmacodynamics of a novel cell therapy. The Core will supply statistical and clinical leadership and input towards those efforts and the developmental programs.