Biostatistics Core

生物统计学核心

• 批准号: 8588552
• 负责人: Matthew D Ringel
• 金额: $ 14.08万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-25 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8588552
• 关键词: Address; Adherence; Biological; Biological Markers; Biometry; Biostatistics Core; Cancer Center; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Communication; Complex; Conduct Clinical Trials; Data; Data Analyses; Data Display; Data Quality; Development; Drug Formulations; Ensure; Experimental Designs; Inferior; Instruction; Investigation; Laboratories; Lead; Literature; Maintenance; Malignant neoplasm of thyroid; Mentors; Methodology; Methods; Observational Study; Ohio; Online Systems; Pilot Projects; Play; Procedures; Prospective Studies; Quality Control; Randomized; Reporting; Research; Research Infrastructure; Research Methodology; Research Personnel; Resources; Retrospective Studies; Role; Sample Size; Security; Services; Staging; Statistical Methods; Statistical Models; Statistical Study; Statistical sensitivity; TNFRSF5 gene; Testing; Thinking; Training; Universities; Validation; Visual; base; biobank; data integration; data integrity; data management; design; expectation; experience; meetings; predictive modeling; quality assurance; repository; research study; success

The principal objective of the Biostatistics Core will be to provide project investigators a centralized resource for biostatistics expertise. Statistical issues will be addressed at all levels of investigation: from the design of clinical trials and laboratory experiments, to the maintenance of data quality; and from conclusions based on formal hypothesis testing, to important leads discovered by thorough data exploration. In support of this objective, the specific aims of the Core include: 1. Design: collaborate with project investigators in the design of clinical studies and laboratory experiments, formulation of unambiguous hypotheses and hypothesis testing strategies, and development and validation of predictive models. Analysis: provide support with: formal hypothesis tests in clinical and experimental data that ensure strong conclusions; statistical modeling and sensitivity analyses of prospective and retrospective studies; integrated analyses for discovery, training, and validation of predictive models; exploratory analyses that lead to further studies and experiments; and visual displays of data that clarify conclusions and uncover leads. Oversight and Infrastructure: provide oversight for the clinical trials, including design adherence and interim analyses, web based randomization, and data coordination services. Data Quality Assurance: manage data and coordinate services with the Integrated Clinicopathology and Biorepository Core to ensure high quality, security and investigator accessibility for all clinical and experimental data. Methods Research: Investigate new methodologies to directly address difficult data or design problems. Pilot projects: provide design and data analytic support for pilot projects. RELEVANCE (See instructions): The Biostatistics Core will provide critical support for planning and design of experiments and studies, statistical analyses and display of data, and data management and integrity. This support is designed to ensure that studies yield reliable conclusions, resources are efficiently used, and exploratory analyses uncover important leads.

生物统计学核心的主要目标是为项目研究者提供集中的资源 生物统计学专业知识。统计问题将在调查的各个层面得到解决：从设计 临床试验和实验室实验，以维护数据质量;并从结论的基础上， 正式的假设检验，通过彻底的数据探索发现的重要线索。为支持这一 目标，核心的具体目标包括： 1.设计：与项目研究者合作设计临床研究和实验室 实验，明确假设和假设检验策略的制定，以及 开发和验证预测模型。 分析：提供支持：临床和实验数据中的正式假设检验，确保 强有力的结论;前瞻性和回顾性的统计建模和敏感性分析 研究;用于发现、训练和验证预测模型的综合分析;探索性 分析，导致进一步的研究和实验;和数据的可视化显示，澄清 结论和发现线索。 监督和基础设施：为临床试验提供监督，包括设计依从性和 中期分析、基于网络的随机化和数据协调服务。 数据质量保证：管理数据并与集成临床病理学协调服务 和生物库核心，以确保所有临床研究的高质量、安全性和研究者可访问性。 和实验数据。 方法研究：研究新的方法，直接解决困难的数据或设计 问题 试点项目：为试点项目提供设计和数据分析支持。 相关性（参见说明）： 生物统计学核心将为实验和研究的规划和设计提供关键支持， 统计分析和数据显示，以及数据管理和完整性。这种支持旨在 确保研究得出可靠的结论，资源得到有效利用，探索性分析 发现重要线索