Heart Failure Clinical Research Network Coordinating Center

心力衰竭临床研究网络协调中心

• 批准号: 8796126
• 负责人: Kevin J Anstrom
• 金额: $ 544.72万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2015-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8796126
• 关键词: Ancillary Study; Attention; Certification; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Complex; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Element; Data Storage and Retrieval; Diagnosis; Economic Development; Enrollment; Ensure; Functional disorder; Funding; Goals; Grant; Guidelines; Heart failure; Human Resources; Informed Consent; Institutes; Instruction; International; Journals; Leadership; Legal; Manuals; Measures; Medical Economics; Methodology; Modeling; Monitor; National Heart, Lung, and Blood Institute; Occupational activity of managing finances; Outcome; Patient Monitoring; Patient Outcomes Assessments; Patients; Performance; Pharmaceutical Preparations; Phase; Procedures; Protocols documentation; Publications; Quality Control; Quality of life; Randomized; Reporting; Research; Research Design; Research Infrastructure; Research Institute; Research Personnel; Resources; Review Committee; Sample Size; Site; Standardization; Statistical Methods; Structure; Subgroup; System; Technology; Therapy Evaluation; Time; Training; Vendor; Work; clinical care; clinical research site; data management; design; editorial; electronic data; experience; improved; innovation; interest; lectures; meetings; novel; operation; protocol development; response; translational medicine; trial design; web site

The National Heart, Lung, and Blood Institute has solicited applications to continue the Heart Failure (HF) Clinical Research Netv^/ork (Network) to accelerate research in the diagnosis and management of HF and to improve patient outcomes through optimal application of existing therapies and evaluation of novel therapies. The Duke Clinical Research Institute (DCRI) proposes to serve as the combined Data Coordinating Center/Clinical Coordinating Center (CC) to provide the essential thought leadership, infrastructure, clinical and research experience, and innovative ideas necessary to support the operations and efficiency of the Network. As CC for the Network, the DCRI will support the following Specific Aims: 1) Coordinate the overall activities of the Network, Network Committees, and Core Labs, and work with the NHLBI and Steering Committee to establish reliable and efficient communication structures, 2) Provide thought leadership and operational support for trial design and protocol development, including the identification of relevant clinical endpoints, appropriate study sample sizes, randomization strategies, and the development of economic and quality-of- life endpoints, 3) Develop the Network Manual of Procedures, provide training and certification for study personnel at all clinical centers, perform site monitoring and develop performance trackers, and coordinate subcontracting including all financial and legal arrangements, 4) Establish a financial reimbursement model that will facilitate enrollment in Network studies; manage and distribute protocol funds to the clinical centers, core labs, and other vendors, 5) Develop and manage an Electronic Data Capture system, including training, quality control, data storage, and reporting, 6) Develop rigorous statistical analysis plans for each study, identifying the appropriate analytical methodology, timing of interim analyses, and a priori subgroups of interest, 7) Provide editorial, technical, and administrative support for all study publications and work with the Steering Committee to effectively communicate the findings of the HFN studies. RELEVANCE (See instructions): The DCRI will support further innovations in heart failure clinical trials that will allow the Network to complete a number of landmark trials over the next 7 years. These trials will change professional guidelines, will provide the Phase II data necessary for appropriate large outcomes trials, and will ultimately improve clinical care of patients suffering with heart failure.

国家心脏，肺和血液研究所已征求申请继续心力衰竭（HF） 临床研究NetV^/ORK（网络），以加快HF诊断和管理的研究 通过最佳应用现有疗法和评估新疗法来改善患者的预后。 杜克临床研究所（DCRI）提议作为合并数据协调 中心/临床协调中心（CC）提供基本的思想领导力，基础设施，临床 以及研究经验以及支持的运营和效率所必需的创新思想 网络。 作为网络的CC，DCRI将支持以下特定目的：1）协调整体活动 网络，网络委员会和核心实验室，并与NHLBI和指导委员会合作 建立可靠，高效的沟通结构，2）提供思想领导和运营 支持试验设计和协议开发，包括识别相关临床终点， 适当的研究样本大小，随机策略以及经济和经济质量的发展 生命终点，3）制定程序的网络手册，为学习提供培训和认证 所有临床中心的人员，执行现场监控和开发性能跟踪器并协调 分包包括所有财务和法律安排，4）建立财务报销模型 这将有助于参与网络研究；管理和分配方案资金到临床中心， 核心实验室和其他供应商，5）开发和管理电子数据捕获系统，包括培训， 质量控制，数据存储和报告，6）为每项研究制定严格的统计分析计划， 识别适当的分析方法，临时分析的时机和先验子组 兴趣，7）为所有研究出版物提供社论，技术和行政支持，并与 指导委员会有效地传达了HFN研究的结果。 相关性（请参阅说明）： DCRI将支持心力衰竭临床试验的进一步创新，这将使网络完成 在未来7年内进行了许多具有里程碑意义的试验。这些试验将改变专业准则，将 提供适当大型结果试验所需的II期数据，并最终改善临床 照顾患有心力衰竭的患者。