AlcHepNet DCC UMMS
AlcHepNet DCC UMMS
基本信息
- 批准号:10887820
- 负责人:
- 金额:$ 11.71万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-08-01 至 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:AccelerationAddressAlcoholic HepatitisAreaBioinformaticsBiological AssayBiological Specimen BanksBiometryBudgetsClinical TrialsCommon Data ElementCommunicationCommunication ToolsCommunitiesCompanionsComplexDataData Coordinating CenterDepositionDevelopmentDocumentationEnsureEquipment and supply inventoriesFundingHealth SciencesIndianaInfrastructureLaboratoriesLeadershipLiverMassachusettsMeasuresMeta-AnalysisMethodologyMethodsMonitorMorbidity - disease rateNational Institute on Alcohol Abuse and AlcoholismNatural HistoryOutcomePatientsPharmaceutical PreparationsPhasePilot ProjectsProcessProtocols documentationPublishingQuality ControlRandomizedReportingReproducibilityResearchResearch DesignRiskSafetyServicesSiteSpeedStatistical Data InterpretationStructureSystemTechnologyTestingUnited States National Institutes of HealthUniversitiesbiobankdata cleaningdata frameworkdata harmonizationdata librarydata managementdata portaldata reductiondata repositorydesignexperienceimplementation facilitationinnovationmedical schoolsmeetingsmortalitynoveloperationpreclinical studyprogramsquality assuranceresponsesymposiumsynergismtherapeutically effectivetimelinetooltranslational study
项目摘要
Abstract
Alcoholic hepatitis (AH) is a leading cause of liver-related morbidity and mortality with a remarkable paucity of
effective therapeutics. NIAAA has sponsored a number of RFAs to form the Alcoholic Hepatitis Network
(AlcHepNet). Collectively, the network will synergize efforts and expertise to better understand AH and develop
novel effective and safe therapies for severe AH. Because of the diversity of studies that will be proposed
under these RFAs, two Data Coordinating Centers will be established to better support these studies efficiently
and effectively to produce high quality reproducible research from each funded study.
This application is for the Data Coordinating Center at the University of Massachusetts Medical School (DCC
UMMS) for AlcHepNet which will provide the statistical and data management leadership to: (1) translational
studies, (2) basic/pre-clinical studies, and (3) pilot clinical trials while using innovations based on previous
experience to facilitate the operations of these studies with shorter timelines and greater quality. The DCC
UMMS Team, housed in the Quantitative Methods Core (QMC) of the Department of Quantitative Health
Sciences, is experienced in both NIH and FDA clinical trials and has implemented a number of proven,
validated approaches in short timeframes and with minimal budgets with increased use of technology and
monitoring tools. The Specific Aims of this proposal are: (1) Efficient and Effective Project Management -
develop a robust infrastructure including communication support and administrative services to facilitate study
objectives; (2) Rigorous Design and Analysis - provide high-level leadership in biostatistics and data
management to the scientific methodology of the DCC UMMS supported studies; and (3) High Quality Study
Implementation - ensure high quality of study results through a rigorous program of quality assurance and
control, study monitoring, and DSMB and regulatory reporting.
Each of these specific aims comprises a set of complex issues that determine efficiency and quality of
implementation. Each will be addressed using multifaceted approaches that can address multiple issues at
once. While there is a need for nimble response to changing needs across studies, there is also need for
measured and documented approaches within the procedural/SOP framework of the DCC UMMS so that each
approach is integrated within the DCC UMMS systems and contributes to higher quality, more reliable data and
reproducible research.
摘要
酒精性肝炎(AH)是肝脏相关发病率和死亡率的主要原因,
有效的治疗方法。NIAAA赞助了一些RFA,以形成酒精性肝炎网络
(AlcHepNet).总的来说,该网络将协同努力和专业知识,以更好地了解AH和发展
治疗重度AH的新型有效且安全的疗法。由于将提出的研究的多样性,
根据这些区域合作协定,将建立两个数据协调中心,以便更有效地支持这些研究
并有效地从每个资助的研究中产生高质量的可重复研究。
此应用程序适用于马萨诸塞州医学院(DCC)的数据协调中心
UMMS)的AlcHepNet将提供统计和数据管理领导:(1)翻译
研究,(2)基础/临床前研究,和(3)试点临床试验,同时使用基于以前的创新
这些研究的目的是提供经验,以促进这些研究的运作,缩短时间,提高质量。的DCC
UMMS团队,位于定量健康部的定量方法核心(QMC)
科学,在NIH和FDA的临床试验中经验丰富,并已实施了许多经过验证的,
在较短的时间内,以最少的预算,更多地利用技术,
监测工具。本提案的具体目标是:(1)高效和有效的项目管理-
建立健全的基础设施,包括通信支持和行政服务,以促进研究
目标;(2)严格的设计和分析-在生物统计学和数据方面提供高水平的领导
管理DCC UMMS支持研究的科学方法;以及(3)高质量研究
实施-通过严格的质量保证计划确保高质量的研究结果,
对照、研究监查、DSMB和监管报告。
这些具体目标中的每一个都包括一系列复杂的问题,这些问题决定了
实施.每一个问题都将采用多方面的方法加以解决,这些方法可以解决多个问题,
一次虽然需要灵活应对各项研究不断变化的需求,但也需要
在DCC UMMS的程序/SOP框架内测量和记录方法,
该方法集成在DCC UMMS系统中,有助于获得更高质量、更可靠的数据,
可复制的研究
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Bruce A Barton其他文献
Bruce A Barton的其他文献
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{{ truncateString('Bruce A Barton', 18)}}的其他基金
Silent Cerebral Infarct Multi-Center Clinical Trial -SCC
无症状脑梗塞多中心临床试验-SCC
- 批准号:
7491017 - 财政年份:2003
- 资助金额:
$ 11.71万 - 项目类别:
Silent Cerebral Infarct Multi-Center Clinical Trial -SCC
无症状脑梗塞多中心临床试验-SCC
- 批准号:
7869498 - 财政年份:2003
- 资助金额:
$ 11.71万 - 项目类别:
Silent Cerebral Infarct Multi-Center Clinical Trial -SCC
无症状脑梗死多中心临床试验-SCC
- 批准号:
6805526 - 财政年份:2003
- 资助金额:
$ 11.71万 - 项目类别:
Silent Cerebral Infarct Multi-Center Clinical Trial -SCC
无症状脑梗死多中心临床试验-SCC
- 批准号:
6681159 - 财政年份:2003
- 资助金额:
$ 11.71万 - 项目类别:
Silent Cerebral Infarct Multi-Center Clinical Trial -SCC
无症状脑梗死多中心临床试验-SCC
- 批准号:
7094063 - 财政年份:2003
- 资助金额:
$ 11.71万 - 项目类别:
Silent Cerebral Infarct Multi-Center Clinical Trial -SCC
无症状脑梗死多中心临床试验-SCC
- 批准号:
6931495 - 财政年份:2003
- 资助金额:
$ 11.71万 - 项目类别:
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