Administration and Data Analysis

管理和数据分析

• 批准号: 6984601
• 负责人: KENNETH A. KROHN
• 金额: $ 20.88万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-10 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6984601
• 关键词: biomedical facility; clinical research; computer data analysis; data management; human data; mathematical model; statistical service /center

This grant will be under the administrative cognizance of the Department of Radiology within the School of Medicine. The department is professionally supported by the School of Medicine staff and the central university Grant and Contract Services organization. The PI, KA Krohn, and the co-PI, JF Eary, meet weekly with the project and core directors to review the progress of the research and to insure effective use of core resources by scheduling imaging studies. In addition, the administrative core will include data analysis and statistics. The data analysis and modeling group provides mathematical analysis of the kinetics of radiopharmaceutical biodistribution as both a research and a service component. In particular, we will extend mixture analysis to each of the projects over the next five years and apply novel heterogeneity analysis to the characterization of tumors using PET imaging. In order to increase the level of biostatistical involvement in protocol design and hypothesis testing, we have two small sub-contracts that are essential to the quality and overall productivity of our research program. The clinical utility of image-based information needs to be tested in terms of what additional information the PET-derived measurements contribute to the prediction of patient outcome at the treatment planning stage. Each of our hypotheses describes an observational study with imaging data, assays of relevant biomarkers, and measures of patient response/survival. At preset the imaging data is not used to influence patient's treatment, however, our goal is to identify imaging procedures where a clinically important improvement in predictive accuracy, beyond that attained with existing clinical and diagnostic methods, can be achieved. Because the improved prediction will have clear therapeutic implications and our results will pave the way for these hypotheses to be tested in future cooperative clinical trials, the consultants in biostatistics play a critical role in focusing protocols and directing data analysis in anticipation of cooperative prospective trials.

这笔赠款将由医学院内的放射科负责行政管理。该系由医学院工作人员和中央大学助学金和合同服务组织提供专业支持。Ka Krohn和联席PI JF Eary每周与项目和核心主管会面，审查研究进展，并通过安排成像研究来确保核心资源的有效利用。此外，行政核心将包括数据分析和统计。数据分析和建模小组提供放射性药物生物分布动力学的数学分析，作为研究和服务的组成部分。特别是，我们将在未来五年内将混合物分析扩展到每个项目，并使用PET成像将新的异质性分析应用于肿瘤的表征。为了提高生物统计学在方案设计和假设检验中的参与程度，我们有两个对我们研究计划的质量和整体生产率至关重要的小分包合同。基于图像的信息的临床实用性需要根据PET衍生的测量对预测患者治疗结果的哪些额外信息进行测试 规划阶段。我们的每个假设都描述了一项观察性研究，包括成像数据、相关生物标记物的分析以及患者反应/存活的测量。在预设的情况下，成像数据不用于影响患者的治疗，然而，我们的目标是确定能够在预测准确性方面实现临床上重要改进的成像程序，而不仅仅是现有的临床和诊断方法。由于改进的预测将具有明确的治疗意义，并且我们的结果将为这些假设在未来的合作临床试验中进行测试铺平道路，生物统计学的顾问在聚焦方案和指导预期合作前瞻性试验的数据分析方面发挥着关键作用。