Biostatistics Core

生物统计学核心

• 批准号: 9340313
• 负责人: DONALD A BERRY
• 金额: $ 6.19万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-22 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9340313
• 关键词: Address; Administrator; Area; Authorization documentation; Berry; Biometry; Biostatistics Core; Biostatistics Shared Resource; Cancer Center; Clinical Research; Clinical Trials; Collaborations; Communication; Conduct Clinical Trials; Consultations; Data; Data Analyses; Data Collection; Data Set; Databases; Development; Ensure; Environment; Futility; Human Resources; Institute of Medicine (U.S.); Institutes; Institution; Laboratories; Manuscripts; Medical center; Medicine; Molecular Medicine; Monitor; NCI-Designated Cancer Center; Online Systems; Patients; Phase I Clinical Trials; Phase II Clinical Trials; Preparation; Principal Investigator; Protocol Compliance; Quality Control; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Safety; Secure; Security; Services; Site; Statistical Study; System; Texas; Toxic effect; Umbilical Cord Blood Transplantation; Universities; University of Texas M D Anderson Cancer Center; Validation; Walking; college; data management; design; experience; improved; innovation; meetings; member; novel; pre-clinical; preclinical study; programs; research facility; success; tool; translational study; web site; wiki

Core B will provide comprehensive and centralized support that integrates the biostatistical activities and data management for the clinical trials and laboratory projects proposed by investigators from the MD Anderson Cancer Center (MDACC), Baylor College of Medicine (BCM) and the University of Texas Institute of Molecular Medicine (IMM). Core Director, Dr. Donald A. Berry, and the Co-Director, Dr. Hao Liu, will coordinate the biostatistical support using a centralized web-based data management system. Core activities will be a team effort, with every member contributing his/her area of specialization. Team members from MDACC and BCM have substantial experience in collaborative activities. Explicit issues addressed in this Core include statistical study design, data analysis and data management. Core B provides statistical support for all projects, including the related data management and computing components. The specific aims of Core B are to: 1) coordinate and manage the statistical activities to ensure that investigators have ready and dedicated access to biostatistical consultation, 2) provide statistical design, planning, and conduct of clinical trials and preclinical validation, 3) provide comprehensive support for data analysis including futility/safety/toxicity monitoring, interim reviews of data, final analysis, interpretation and reporting, and 4) coordinate data management activities in close collaboration with the Administrative Core. In addition, Core B will support the bi-institutional clinical trials (MDACC and BCM only) of all Projects by providing computing facilities and resources for research requirements and by implementing patient-specific data management. This includes data review, transfer, sharing, and security as well as quality control and protocol compliance. This Core will provide biostatistical support to all four research Projects. Centralized biostatistical support will ensure that biostatisticians are familiar with the unique as well as the interrelated aspects of each Project and provide and infrastructure for interactions among biostatisticians and investigators. Consequently, this will 1) facilitate efficient use of biostatistical services, 2) provide an opportunity for dynamic collaboration between biostatisticians and investigators in the design, conduct, and interpretation of data resulting from the Projects, and 3) ensure the conduct of high-quality projects in a tri-institutional environment. The Core personnel are highly experienced biostatisticians who are members of the Biostatistics Shared Resources of MDACC and the Dan L. Duncan Cancer Center at BCM.

核心B将为MD安德森癌症中心（MDACC）、贝勒医学院（Baylor College of Medicine）和德克萨斯大学分子医学研究所（IMM）的研究者提出的临床试验和实验室项目提供全面和集中的支持，整合生物统计活动和数据管理。核心总监Donald A. Berry和联合主任Hao Liu博士将使用集中的基于网络的数据管理系统协调生物统计支持。核心活动将是一个团队的努力，每个成员贡献他/她的专业领域。来自MDACC和EMBA的团队成员在合作活动方面具有丰富的经验。本核心文件明确涉及的问题包括统计研究设计、数据分析和数据管理。核心B为所有项目提供统计支持，包括相关的数据管理和计算组件。核心B的具体目标是：1）协调和管理统计活动，以确保研究者能够随时获得专门的生物统计咨询，2）提供临床试验和临床前验证的统计设计、规划和实施，3）为数据分析提供全面支持，包括无效性/安全性/毒性监测、数据中期审查、最终分析、解释和报告，4）与行政核心密切合作，协调数据管理活动。此外，核心B将通过提供研究所需的计算设施和资源以及实施患者特定的数据管理，支持所有项目的双机构临床试验（仅MDACC和EQUIPMENT）。这包括数据审查、传输、共享和安全性以及质量控制和方案合规性。该核心将为所有四个研究项目提供生物统计支持。集中的生物统计支持将确保生物统计学家熟悉每个项目的独特性和相互关联的方面，并为生物统计学家和研究者之间的互动提供基础设施。因此，这将1）促进生物统计服务的有效利用，2）为生物统计学家和研究人员在设计，实施和解释项目数据方面提供动态合作的机会，以及3）确保在三机构环境中开展高质量的项目。核心人员是经验丰富的生物统计学家，他们是MDACC和Dan L.华盛顿的邓肯癌症中心。