Sub-component for Institution # 16-01848 Biostatistics

生物统计核心(核心2)的主要目标将是提供具有成本效益的、全面的和关键的 对P01应用程序的四个项目和核心的支持，该应用程序的标题为：使本地访问最大化 胶质母细胞瘤的治疗性分娩“。为此，Core 2组建了一支经验丰富的教职员工团队， 工作人员统计员和程序员。生物统计核心也将作为所有 项目的各个阶段。核心2的成员将承担(并已经承担)以下主要责任 方法、统计和与计算机有关的问题，包括所有项目的研究设计；数据收集； 数据录入和分析；质量控制；计算机联网；数据库管理；统计方法 发展；参与手稿的准备工作。 CORE 2与每个项目负责人合作，确保每个研究设计都足以满足所有主要需求 假设。这包括细化研究假设，确定主要的(必要时，次要的) 每项研究的终点；确定检验每个假设所需的样本量 能力和意义水平，并评估每项研究相对于其假设和 预计可用主题池。CORE 2精心设计了每个项目的统计分析计划 根据需要包含标准和高级统计方法的组合。这包括使用 说明重复测量的纵向数据的方法，以及在需要时处理丢失数据的方法 发生。此外，核心2成员将寻找机会开发新的统计方法以进行分析 提案中对成像数据和这些方法进行了描述。 为了保证这些方法的成功实施，核心2成员承诺 积极参与每个项目的日常活动。对于每个项目，核心2成员中的一名将服务于 作为联合调查员，并参加该项目调查员之间的定期会议。这一模式 核心2成员和科学研究人员之间的合作已在癌症组织内实施 在维克森林大学工作多年，取得了巨大的成功。总之，生物统计核心是一个 本P01的不可分割的组成部分。它将四个项目连接在一起，并通过提供 集中化的分析和数据管理支持，可有效传播结果 在项目和核心之间，并进入科学界。

The primary goal of the Biostatistics Core (Core 2) will be to provide cost-effective, comprehensive and critical support to the four projects and cores from this P01 application entitled “Maximizing Local Access to Therapeutic Deliveries in Glioblastoma”. To do this Core 2 has assembled a team of experienced faculty and staff statisticians and programmers. The Biostatistics Core will also act as a central resource throughout all phases of the project. Members of Core 2 will assume (and has assumed) major responsibilities for methodological, statistical, and computer-related issues, including study design for all projects; data collection, data entry, and analyses; quality control; computer networking; database management; statistical methodology development; and participation in manuscript preparation. Core 2 has worked with each Project Leader to insure that each study design is adequate to address all major hypotheses. This has involved refining study hypotheses, defining primary (and when necessary, secondary) end points for each study; determining the sample sizes necessary to test each hypothesis with a specified power and level of significance, and assessing the feasibility of each study relative to its hypothesis and the projected available subject pool. Core 2 has taken care to design the statistical analysis plans for each project to contain a combination of standard and advanced statistical methods as needed. This includes using methods for longitudinal data that account for repeated measures as well as handling missing data if it were to occur. In addition, Core 2 members will look for opportunities to develop new statistical methods for analyzing imaging data and these approaches are described in the proposal. To guarantee that successful implementation of these methods occurs, Core 2 members are committed to taking an active part in the daily activities of each project. For each project one of Core 2 members will serve as a co-investigator and participate in regular meetings among investigators for that project. This model of collaboration among Core 2 members and scientific investigators has been implemented within the Cancer Center at Wake Forest University for many years with great success. In conclusion, the Biostatistics Core is an integral component of this P01. It connects the four projects together and supports all other Cores by providing centralized analytic and data management support that will allow efficient dissemination of results to flow among projects and cores, and into the scientific community.