Shared Resources-Clinical Research Services

共享资源-临床研究服务

• 批准号: 8132534
• 负责人: William K. Kelly
• 金额: $ 15.58万
• 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/8132534
• 关键词: Address; Area; Basic Science; Biometry; Biostatistics Core; Biostatistics Shared Resource; Cancer Center; Clinical; Clinical Research; Clinical Sciences; Clinical Services; Clinical Trials; 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

生物统计共享资源为青年会的三个主要方案领域提供支持： 临床科学、基础科学和人口科学。提供的服务包括：生物统计学 支持研究项目，协助新研究项目的统计和研究方面 和拨款申请、数据分析和培训/因此，这一核心对临床试验/研究设计至关重要 进程。此外，该核心主要负责支持议定书审查和监测。 YCC的进程。因此，此共享资源为以下各项提供了关键支持 统计服务，从研究设计到最终研究报告的撰写。2005年末，西奥多博士 霍尔福德接受了这一核心设施的主任职位。霍尔福德博士将与丹尼尔博士密切合作 Zelterman是生物统计共享资源的联合主任。共享的生物统计学 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 与六名致力于青年理事会的博士统计学家进行了积极协商。对美国的两大批评 已解决之前的续签问题。具体地说，成立了生物统计学临床研究小组， 由霍尔福德博士担任主席，确保生物统计学专业知识应用于议定书审查委员会 对前瞻性临床试验的评估将与特定研究的评估完全不同 累积数据的设计和后续分析。此外，生物统计工作人员已经显著地 扩大，为研究人员发起的临床研究的显著增加提供全面覆盖 活动，由于招募了大量新的临床研究人员。在过去的2年中 多年来，已有11名新的临床肿瘤学家加入YCC，他们的临床试验工作领导了 到所需的生物统计学支持增加56%。为了支持这些增加的需求， 此共享资源的教师生物统计师员工已从2人增加到7人。在此续订申请中，我们 正在为下一阶段的资金申请1.75FTE。 2005年，在所有8项YCC调查中，用户100%(即42人)是YCC成员(65.5%经过同行评审) 节目