Core--Biostatistics/Data Managemente

核心--生物统计/数据管理e

• 批准号: 7102936
• 负责人: SCOTT M LIPPMAN
• 金额: $ 27.77万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7102936
• 关键词: biomedical facility; data collection methodology /evaluation; data management; prostate neoplasms; statistical service /center; statistics /biometry

DESCRIPTION (provided by applicant): The primary objectives of Core B are to support development of study design, management of data collection, and performance of statistical analyses to validly test the research hypotheses and questions under investigation in the Biology of the Prostate Cancer Prevention Trial (PCPT) Program Project. Core B will play a pivotal role in the Program Project, interacting with every Project and Core. In the study-design phase, Core B will assist investigators in formulating studies that can feasibly address the questions of scientific interest, are amenable to analysis by statistical and data-mining methods, and will ultimately yield statistically valid and interpretable results. An equally important role for Core B will be database design and coordination of the selection, shipping, and accumulation of results from analyses on serum, white blood cell and tissue samples. This Core will be responsible for managing the overall data infrastructure for all Projects and Cores involved in this program project. This includes maintaining the clinical database, electronic transfer of lab data over secure pathways, tracking samples and verifying that the necessary material is sent to the correct laboratory at the correct time, and ensuring the security and confidentiality of all data. This core will also provide uniform high-quality support for all statistical analyses, using both standard and specialized biostatistical methods. The overall goal of this program project is to identify factors that are associated with prostate cancer and high grade prostate cancer, and to identify factors that may predict who may and may not respond to finasteride treatment for the prevention of prostate cancer. The revised Project addresses all reviewer concerns, including those for justifying expected effect sizes and clarifying our approach to multiple testing of polymorphisms.

描述(由申请人提供)：核心B的主要目标是支持 开发研究设计、数据收集管理和统计分析的性能，以有效地检验前列腺癌预防生物学试验(PCPT)计划项目中正在调查的研究假设和问题。核心B将在计划项目中发挥关键作用，与每个项目和核心进行互动。在研究设计阶段，核心B将协助调查人员拟定研究报告，这些研究报告可以可行地解决科学上感兴趣的问题，能够通过统计和数据挖掘方法进行分析，最终将产生统计上有效和可解释的结果。核心B的一个同样重要的作用将是数据库设计和对血清、白细胞和组织样本的分析结果的选择、运输和积累的协调。此核心将负责管理此计划项目中涉及的所有项目和核心的整体数据基础架构。这包括维护临床数据库、通过安全路径电子传输实验室数据、跟踪样本并核实必要的材料在正确的时间被送到正确的实验室，以及确保所有 数据。该核心还将使用标准和专门的生物统计方法，为所有统计分析提供统一的高质量支持。该计划项目的总体目标是确定与前列腺癌和高级别前列腺癌相关的因素，并确定可能预测谁可能对预防前列腺癌的非那雄胺治疗有反应的因素。修订后的项目解决了所有审查者关注的问题，包括证明预期效果大小的合理性和澄清我们对多态测试的方法。