Core 3: Biostatistics Core

项目摘要-核心3 生物统计核心(核心3)的主要目标是为项目调查人员提供集中的 生物统计专业知识的资源。统计问题将在各级调查中得到解决： 实验和临床试验的设计，到数据质量的维护；以及根据以下结论 正式的假设检验，通过彻底的数据探索发现重要线索。《公约》的具体目标 核心是：1.1。与项目调查人员合作，制定明确的假设和 假设检验策略，以及在实验设计中。生物统计合作将提供帮助 研究人员在设计阶段：将生物学和临床问题作为可检验的统计学问题 假设；设计有效的实验设计，并将这些设计与适当的统计模型相匹配； 确定确保高功率所需的样本量；以及强有力的控制。1.2.为…提供支持 所有项目：在实验和临床数据中进行正式的假设检验，以确保 结论；导致进一步实验、改进假设或发现的探索性分析； 复杂数据的统计建模和敏感性分析；以及数据的可视化显示，以澄清 结论和发现线索。核心3统计学家与调查人员广泛合作，开发出 全面的分析计划，区分正式测试(这为强大的 基于先前科学知识/实验的结论)和探索性分析(这不允许 寻求强有力的结论，但为重要发现奠定基础)。核心统计员将雇用最多的 用于建模和敏感性分析的可靠方法，以确保结果的可靠性。对于所有数据，可视显示 将强调这一点，以揭示结论的可靠性，并帮助发现新的线索。1.3. 提供数据管理和集成服务，确保高度的完整性、安全性和调查性 可访问性。确保项目间统计分析的一致性和透明度，并拥有 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， 核心3将拥有一个所有数据的中央储存库，调查人员可以访问该储存库。数据将 被清理、合并和取消身份识别。所有丢失和离岸的数据都将报告给调查人员。核心3将 确保项目间相同数据类型的分析计划和报告的一致性。1.4.开发新的 统计方法，直接处理项目中出现的复杂数据或设计问题 目前的统计方法不适用的地方。当面对这些项目中出现的具体问题时 如果当前的统计方法不适用，则核心3人员将调整可用的方法或开发 解决这些问题的新程序。

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.