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的主要目的是支持 研究设计的开发、数据收集的管理和统计分析的执行，以有效地检验前列腺癌预防试验（PCPT）项目生物学研究中的研究假设和问题。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交互。在研究设计阶段，核心B将协助研究者制定研究，这些研究可以可行地解决科学感兴趣的问题，可以通过统计和数据挖掘方法进行分析，并最终产生统计学有效和可解释的结果。核心B的一个同等重要的角色是数据库设计和协调血清、白色血细胞和组织样本分析结果的选择、运输和积累。该核心将负责管理本计划项目中涉及的所有项目和核心的整体数据基础设施。这包括维护临床数据库，通过安全途径以电子方式传输实验室数据，跟踪样本并验证必要的材料是否在正确的时间发送到正确的实验室，以及确保所有数据的安全性和机密性。 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，并确定可能预测哪些人可能对预防前列腺癌的芬普胺治疗有反应或无反应的因素。修订后的项目解决了所有评审员关注的问题，包括证明预期效应大小的合理性和澄清我们对多态性多重检测的方法。