Shared Resources-Clinical Research Services

共享资源-临床研究服务

• 批准号: 7916706
• 负责人: William K. Kelly
• 金额: $ 14.1万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7916706
• 关键词: Address; Area; Basic Science; Biometry; Biostatistics Core; Biostatistics Shared Resource; Cancer Center; Clinical; Clinical Research; Clinical Sciences; Clinical Services; Clinical Trials; Comprehensive Cancer Center; Consultations; Core Facility; Data; Data Analyses; Doctor of Philosophy; Ensure; Epidemiologist; Evaluation; Faculty; Funding; Leadership; Malignant Neoplasms; Medicine; Methodology; Methods; Monitor; Oncologist; Peer Review; Population Sciences; Positioning Attribute; Process; Protocols documentation; Public Health; Recruitment Activity; Reporting; Request for Applications; Research; Research Activity; Research Design; Research Personnel; Research Project Grants; Resolution; Resource Sharing; Resources; Review Committee; Services; Strategic Planning; Students; Time; Training; Translational Research; Work; Writing; clinical infrastructure; epidemiology study; frontier; member; programs; prospective; statistical service; tool

The Biostatistics Shared Resource provides support for the three broad major programmatic areas of YCC: clinical science; basic science; and population science. The services provided include: biostatistical support to research projects, assistance with the statistical and research aspects of new research projects and grant applications, data analysis, and training/As such, this core is vital to clinical trials/study design process. Additionally, this core has the major responsibility to support the protocol review and monitoring process of the YCC. Thus, this Shared Resource provides critical support for the complete spectrum of statistical services, from study design through the final research report writing. In late 2005, Dr. Theodore Holford accepted the position as Director of this core facility. Dr. Holford will work closely with Dr. Daniel Zelterman, who serves as Co-Director of the Biostatistics Shared Resource. The Biostatistics Shared Resource is Cancer Center Managed and provides statistical support and data analysis to YCC in the form of active consultation with six Ph.D. statisticians dedicated to the YCC. The 2 major criticisms of the previous renewal have been addressed. Specifically, creation of a Biostatistics Clinical Studies Group, chaired by Dr. Holford, ensures that biostatistical expertise applied to Protocol Review Committee evaluation of prospective clinical trials will be completely distinct from that involved in the particular study's design and subsequent analysis of accrued data. In addition, the biostatistical staff has been significantly expanded, to provide full coverage for the marked increase in investigator-initiated clinical research activities, resulting from the recruitment of a large number of new clinical researchers. Over the past 2 years, 11 new investigative clinical oncologists have joined the YCC, and their clinical trials efforts have led to a 56% increase in the required biostatistical support. In order to support these increased needs, the faculty biostatistician staff of this Shared Resource has grown from 2 to 7. In this renewal application, we are requesting 1.75 FTE for the next period of funding. In 2005 100%, or 42, users were YCC members (65.5% Peer reviewed) from all 8 of the YCC research programs

生物统计学共享资源为 YCC 的三大主要计划领域提供支持： 临床科学；基础科学；和人口科学。提供的服务包括：生物统计 支持研究项目，协助新研究项目的统计和研究方面 以及资助申请、数据分析和培训/因此，这一核心对于临床试验/研究设计至关重要 过程。此外，该核心的主要职责是支持协议审查和监控 YCC 的流程。因此，该共享资源为整个范围提供了关键支持 统计服务，从研究设计到最终研究报告的撰写。 2005年底，西奥多博士 霍尔福德接受了该核心设施主任的职位。霍尔福德博士将与丹尼尔博士密切合作 泽尔特曼（Zelterman）担任生物统计共享资源的联合主任。生物统计学共享 资源由癌症中心管理，并以以下形式向 YCC 提供统计支持和数据分析 与六位博士的积极咨询。致力于 YCC 的统计学家。 2个主要批评 之前的续订已得到解决。具体来说，创建生物统计学临床研究小组， 由霍尔福德博士担任主席，确保生物统计专业知识应用于方案审查委员会 前瞻性临床试验的评估将与特定研究中涉及的评估完全不同 累积数据的设计和后续分析。此外，生物统计人员也得到了显着提升。 扩大，为研究者发起的临床研究的显着增加提供全面覆盖 活动的结果是招募了大量新的临床研究人员。过去2 多年来，11 位新的研究临床肿瘤学家加入了 YCC，他们的临床试验工作引领了 所需生物统计支持增加 56%。为了支持这些增加的需求， 该共享资源的教员生物统计学人员已从 2 名增加到 7 名。在此更新应用程序中，我们 正在请求 1.75 FTE 作为下一期的资助。 2005 年，所有 8 项 YCC 研究中，100%（即 42 名）用户是 YCC 成员（65.5% 经过同行评审） 节目