Core C: Biostatistics and Data Management

摘要 生物统计和数据管理核心提供广泛的统计服务，以支持 四个项目。核心将提供临床试验设计方面的建议，例如终点的选择， 可能的分层、考虑和计算样本量和统计功效。核心是 负责本拟议计划项目（P01）中所有四个项目的数据管理的各个方面， “烟草评估方法联盟（COMET）：过滤器通风和产品标准”;我们使用 安全的数据库，特别强调数据完整性和数据质量。核心将制定计划， 使用以下技术，以项目之间一致的标准化格式执行专家统计分析， 核心还将促进中心项目之间的数据共享， 一般科学界。 核心由一名生物统计学家担任方案经理（数据经理）和四名高级 与所有主要研究者有日常工作关系的经验丰富的生物统计学家;四名中的两名 生物统计学家是生物统计学系的高级教师（副教授）。核心 生物统计学家一直是该应用程序开发的一个组成部分，并参与了 生产组的调查人员的最后4-5年，目前COMET赠款。此外，核心 包括俄亥俄州州立大学的一名生物统计学家和一名生物信息学家，他们将专注于 进行涉及复杂多维数据集的研究。 生物统计和数据管理核心的主要目标是为科学和 通过充分参与其活动来实施方案项目。核心生物统计学家有广泛的长期- 临床试验设计、数据收集、数据存储、数据检索、数据分析方面的长期专业知识， 根据需要，对结果进行解释，包括新的和复杂的统计程序。通过提供 专门知识研究方法和后勤支持的数据分析活动与所有三个项目，这 核心将有助于提高数据解释和科学生产力。

ABSTRACT The Biostatistics and Data Management Core provides a broad array of statistical services in support of the four projects. The Core will provide advice on clinical trial design - such as selection of end points and possible stratification, consideration and calculation of sample size and statistical power. The Core is responsible for all aspects of data management in all four projects in this proposed Program Project (P01), “Consortium on Methods Evaluating Tobacco (COMET): Filter Ventilation and Product Standards”; we use secure databases with strong emphasis on data integrity and data quality. The Core will form plans and perform expert statistical analyses in a standardized format consistent between Projects using techniques that are state of the art. The Core will also facilitate data sharing between projects in the Center as well as the general scientific community. The Core is staffed by a biostatistician serving as Protocol Manager (Data Manager) and four highly experienced biostatisticians who have daily working relationships with all principal investigators; two of the four biostatisticians are senior faculty (Associate Professors) of the Division of Biostatistics. The Core biostatisticians have been an integral part in the development of this application and have participated with this productive group of investigators the last 4-5 years of this current COMET grant. Additionally, the Core includes one biostatistician and one bioinformaticians at The Ohio State University who will focus on conducting studies involving complex multi-dimensional datasets. The primary objective of the Biostatistics and Data Management Core is to contribute to the science and operation of the program project by participating fully in its activities. Core biostatisticians have broad long- standing expertise in clinical trial design, data collection, data storage, data retrieval, data analysis, and interpretation of results incorporating novel and complex statistical procedures as needed. By providing expertise research methodology and logistical support to data analytic activities with all three projects, this Core will help to enhance data interpretation and scientific productivity.