Core B: Clinical Trials and Statistics

临床试验和统计核心 项目摘要 临床试验和统计核心(核心B)资源将协作并提供综合统计数据 为本计划项目中的所有研究项目提供临床试验服务和基础设施支持 格兰特。此外，它还将为数据管理和集成、信息学和计算提供支助，以及 协助识别和解决项目活动过程中出现的复杂数据任务。堆芯 成员将在广泛的活动范围内与项目调查人员合作，包括制定 研究设计、数据获取、统计质量控制、临床试验监测、数据分析和 口译、摘要和手稿准备以及数据传播。此外，当 具体项目，核心人员将开发和实施创新的定制生物统计方法 和工具，与P01中的调查人员合作。核心B资源设在 约翰霍普金斯大学医学院肿瘤学系生物统计学和生物信息学。这 该司由一群积极致力于生物统计和生物信息学的教员以及非 学院生物统计学家和生物信息学家，可以使用最先进的设备和广泛的 专业知识。核心成员对P01有强烈的承诺，源于他们长期以来的 与胃肠道癌症项目的合作。所有拟议的项目都使用这一核心 在每一个目标上都有资源。 核心B的主要目标是指导和协助项目调查人员设计、实施和 分析本研究中提出的实验室、翻译和免疫学相关研究以及临床试验 P<0.01。每个项目都有一名主要的生物统计学家，全面精通与 项目，所有项目都可以利用核心人员提供的广泛专业知识。核心成员 还定期与行政核心A以及基因组和生物信息学密切合作 核心C，有助于项目之间的互动和协同。

Clinical trials and Statistics Core Project Summary The Clinical trials and Statistics Core (Core B) Resource will collaborate and provide comprehensive statistics service and infrastructure support for clinical trials to all Research Projects in this proposed Program Project Grant. In addition, it will provide support for data management and integration, informatics, and computing, and assist with the identification and solution of complex data tasks arising in the course of project activities. Core members will work with project investigators across a wide spectrum of activities, encompassing formulation of the study design, data acquisition, statistical quality control, clinical trial monitoring, data analysis and interpretation, abstract and manuscript preparation, and data dissemination. Furthermore, when required by a specific project, Core personnel will develop and implement innovative customized biostatistics methodologies and tools in collaboration with investigators in the P01. The Core B Resource is housed in the Division of Biostatistics and Bioinformatics, Department of Oncology at Johns Hopkins University School of Medicine. This Division comprises an active and committed group of biostatistics and bioinformatics faculty, as well as non- faculty biostatisticians and bioinformaticians, with access to state-of-the art equipment and a broad range of expertise. Core members have a strong commitment to this P01, stemming from their long-standing collaborations with the Gastrointestinal Cancers Program. All proposed Projects make use of this Core Resource in every Aim. The primary objective of Core B is to guide and assist the project investigators in the design, conduct, and analysis of the laboratory, translational and immunologic correlative studies, and clinical trials proposed in this P01. Each project has a primary biostatistician thoroughly versed in the subject matter associated with the project, and all projects have access to the breadth of expertise provided by Core personnel. Core members also interact on a regular basis, and work closely with Administrative Core A and Genomic and Bioinformatics Core C, which contributes to interactions and synergy among the projects.