Biostatistics, Bioinformatics and Environmental Sampling Core

摘要 生物统计学、生物信息学和暴露抽样(BBES)核心将提供一种综合方法来 所有项目涉及1)研究设计，2)吸入暴露评估工具和测量，3) 表型、吸入暴露和分子数据的整合和管理，以及4)生物统计和 生物信息学分析。通过集中这些活动，我们预计这一多学科核心将增加 项目之间以及项目与核心之间的互动程度。这一战略将使我们能够 协调研究设计和数据管理问题，从而实现更一致的暴露方法 评估和数据分析以及显著的成本节约。核心总监(Fingerlin)和 吸入暴露评估负责人(Thornburg)将监督一个有经验的小组进行 研究涉及多学科团队在研究中的协调。团队拥有所需的技能集 处理研究设计、流行病学、基因组学、广泛的定量方法、数据等复杂问题 管理和吸入暴露评估。与项目和核心的互动：BBES核心 将为所有四个项目提供服务。项目将从核心获得研究设计方面的援助，包括 在一项研究开始时，就方法学问题与项目绩效指标进行协商，并作为 研究取得了进展。在索恩伯格博士的指导下，吸入暴露评估 核心的职责将是1)为项目1提供个人暴露监测仪，以及2)量化 根据所有项目将使用的个人监视器的滤镜进行曝光和3) 维护全面的暴露数据集，并将这些数据传输到NJH。核心的数据集成和 管理职责将服务于所有项目以及行政核心，包括：1) 管理数据采集和传输，2)开发和维护研究数据库，3) 确保数据备份、存储和安全。岩心的生物统计学和生物信息学分析 职责包括：1)与项目总监会面以确定分析需求；2)执行 生物统计学分析，以及3)进行生物信息学分析，总结和询问生物统计学 结果在生物途径方面。每个项目都将受益于向其他项目提供的服务； 同样的专家将在所有三个项目上工作，这将确保思想的交流和分享 信息。此外，BBES核心将与临床核心密切互动，以协调两者的暴露 临床表型数据的评估和获取。最后，该核心将与行政部门协调 核心，因为它提供了支持该方案的行政和组织结构，并将获得 行政核心和执行委员会的指示。此核心将与 每月与项目负责人举行行政核心会议，并根据需要提供活动报告 否则的话。核心成员将参加每月的计划会议，并将有个人每月 每个项目的会议；这些会议将错开，以便每周Fingerlin博士和 适当的核心调查人员将与单个项目团队或整个计划会面。这个 从核心到计划的产品包括1)数据集成和分析脚本、全面的 确定的数据集、暴露监测数据、带有文档的数据分析摘要，以及参与 传播的方方面面。这些产品将帮助所有项目和管理核心 履行其研究、报告和资源共享的目标和义务。

Abstract The Biostatistics, Bioinformatics and Exposure Sampling (BBES) Core will provide an integrated approach to all projects with regard to 1) study design, 2) inhalation exposure assessment tools and measurement, 3) integration and management of phenotype, inhalation exposure and molecular data, and 4) biostatistical and bioinformatics analysis. By centralizing these activities, we expect that this multidisciplinary Core will increase the level of interaction among the projects and between projects and the Core. This strategy will allow us to coordinate study design and data management issues, leading to a more coherent approach to exposure assessment and data analysis as well as significant cost savings. The Core Director (Fingerlin) along with the inhalation exposure assessment lead (Thornburg) will supervise a team that is experienced in the conduct of studies involving the coordination of multidisciplinary teams in research. The team has the skill set required to manage complex issues of study design, epidemiology, genomics, broad quantitative methods, data management and inhalation exposure assessment. Interaction with Projects and Cores: The BBES Core will serve all four projects. Projects will receive assistance with Study Design from the Core including consultation with project PIs on methodological issues, at the initiation of a study, and ongoing consultation as the study progresses. Under the direction of Dr. Thornburg, the Inhalation Exposure Assessment responsibilities of the Core will be to 1) provide personal exposure monitors to Project 1, and 2) quantify exposures based on the filters taken from the personal monitors that will be utilized by all projects and 3) maintain comprehensive exposure data sets and transfer these data to NJH. The Core's Data Integration and Management responsibilities will serve all projects as well as the Administrative Core including: 1) management of data acquisition and transfer, 2) development and maintenance of research databases, and 3) ensuring data backup, storage, and security. The Core's Biostatistical and Bioinformatics Analysis responsibilities will include: 1) meeting with Project Directors to determine analysis needs, 2) conducting the biostatistical analyses, and 3) conducting bioinformatic analyses to summarize and interrogate the biostatistical results in terms of biologic pathways. Each project will benefit from the services provided to the other projects; the same experts will work on all three projects, which will ensure cross-fertilization of ideas and sharing of information. In addition, The BBES Core will interact closely with the Clinical Core to coordinate both exposure assessment and capture of clinical phenotype data. Finally, this Core will coordinate with the Administrative Core, as it provides the administrative and organizational structure to support this Program, and will receive direction from the Administrative Core and the Executive Committee. This Core will interact with the Administrative Core at monthly meetings with Project Leaders, and provide reports on its activities as needed otherwise. Members of the Core will attend the monthly Program meetings and will have individual monthly meetings with each project; these meetings will be staggered such that each week Dr. Fingerlin and appropriate Core investigators will meet with either an individual Project team or the entire Program. The products from the Core to the Program include 1) data integration and analysis scripts, comprehensive de- identified data sets, exposure monitor data, data analysis summaries with documentation, and participation in all aspects of dissemination. These products will assist all of the Projects and the Administrative Core in fulfilling their research, reporting and resource sharing goals and obligations.