Core 3: Biostatistics Core

核心 3：生物统计学核心

• 批准号: 10019371
• 负责人: Soledad A Fernandez
• 金额: $ 6.12万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-07 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10019371
• 关键词: Address; Biological; Biometry; Biostatistics Core; Cells; Clinical; Clinical Data; Clinical Trials; Collaborations; Data; Data Display; Development; Ensure; Experimental Designs; Formulation; Human Resources; Investigation; Knowledge; Lead; Maintenance; Malignant Glioma; Measurement; Methodology; Methods; Modeling; Ohio; Outcome Measure; Paper; Procedures; Publishing; Reliability of Results; Reporting; Research; Research Personnel; Resources; Sample Size; Sampling; Science; Secure; Security; Services; Statistical Data Interpretation; Statistical Methods; Statistical Models; Statistical sensitivity; Structure; Testing; Universities; Visual; Work; base; combat; complex data; data exploration; data integration; data integrity; data management; data quality; design; experimental study; meetings; member; novel; oncolytic virotherapy; pre-clinical; primary outcome; repository

PROJECT SUMMARY – CORE 3 The principal objective of the Biostatistics Core (Core 3) is to provide project investigators a centralized resource for biostatistics expertise. Statistical issues will be addressed at all levels of investigation: from the design of experiments and clinical trials, to the maintenance of data quality; and from conclusions based on formal hypothesis testing, to important leads discovered by thorough data exploration. The specific aims of the Core are: 1.1. Collaborate with project investigators in the formulation of unambiguous hypotheses and hypothesis testing strategies, and in the design of experiments. Biostatistics collaboration will assist researchers at the design stage by: formulating biological and clinical questions as testable statistical hypotheses; devising efficient experimental designs and matching these with appropriate statistical models; determining sample sizes necessary to ensure high power; and strongly controlling. 1.2. Provide support for all projects with: formal hypothesis tests in experimental and clinical data that ensure strong conclusions; exploratory analyses that lead to further experiments, refined hypotheses, or discoveries; statistical modeling and sensitivity analyses of complex data; and visual displays of data that clarify conclusions and uncover leads. Core 3 statisticians have worked extensively with investigators to develop comprehensive analysis plans that distinguish between formal testing (which provides evidence for strong conclusions based on prior scientific knowledge/experimentation) and exploratory analyses (which do not allow for strong conclusions, but lay the groundwork for important discoveries). Core statisticians will employ the most robust methods for modeling and sensitivity analyses to ensure reliability of results. For all data, visual displays will be emphasized in order to reveal the reliability of conclusions and aid in the discovery of new leads. 1.3. Provide data management and integration services that ensure high integrity, security and investigator accessibility. Ensure statistical analysis consistency and transparency across projects, and have a centralized repository of all analysis procedures and results. To promote data integration across projects, Core 3 will have a centralized repository of all data that is secure and accessible to the investigators. Data will be cleaned, merged and de-identified. All missing and outlying data will be reported to investigators. Core 3 will ensure consistency of analysis plans and reports for the same data types across projects. 1.4. Develop new statistical methodologies to directly combat complex data or design problems that arise in projects and where current statistical methods do not apply. When faced with specific issues that arise in these projects where current statistical methods do not apply, Core 3 personnel will either adjust available methods or develop novel procedures to address the problems.

项目摘要 - 核心3 生物统计学核心的主要目标（核心3）是为项目调查人员提供集中式调查人员 生物统计学专业知识的资源。统计问题将在各个级别的投资中解决： 设计实验和临床试验，以维持数据质量；从基于的结论 正式的假设检验，通过彻底的数据探索发现的重要潜在客户。特定目标 核心为：1.1。与项目调查员合作，以明确的假设和 假设测试策略以及实验的设计。生物统计学合作将有助于 设计阶段的研究人员通过：将生物学和临床问题制定为可检验的统计 假设；设计有效的实验设计并将其与适当的统计模型相匹配； 确定所需的样本量以确保高功率；并强烈控制。 1.2。提供支持 所有项目都有：实验和临床数据中的正式假设检验，以确保强大 结论；探索性分析导致进一步的实验，精致的假设或发现； 复杂数据的统计建模和灵敏度分析；以及澄清的数据的视觉显示 结论和发现铅。核心3统计学家与调查人员广泛合作以发展 全面的分析计划，以区分正式测试（为强大的证据提供了证据 结论基于先前的科学知识/实验）和探索性分析（这不允许 得出强烈的结论，但为重要发现奠定了基础）。核心统计数据将使用最多 建模和灵敏度分析的强大方法，以确保结果的可靠性。对于所有数据，视觉显示 将强调以揭示结论的可靠性并帮助发现新线索。 1.3。 提供数据管理和集成服务，以确保高完整，安全和调查员 可访问性。确保统计分析一致性和透明的项目，并具有 所有分析程序和结果的集中存储库。为了促进跨项目的数据集成， Core 3将拥有所有可靠和可访问的数据的集中存储库。数据将 被清洁，合并和去识别。所有丢失和外围数据都将报告给调查人员。核心3将 确保对跨项目相同数据类型的分析计划和报告的一致性。 1.4。开发新 统计方法是直接结合项目中出现的复杂数据或设计问题的统计方法 当前统计方法不适用的地方。当面对这些项目中出现的特定问题时 如果当前不适用统计方法，Core 3人员将调整可用方法或开发 解决问题的新型程序。