Heart Failure Clinical Research Network Coordinating Center

国家心脏、肺和血液研究所已征求申请，以继续心力衰竭（HF） 临床研究网络（网络），以加速HF诊断和管理方面的研究， 通过最佳应用现有疗法和评价新疗法改善患者预后。 杜克临床研究所（DCRI）建议作为联合数据协调机构 中心/临床协调中心（CC）提供必要的思想领导、基础设施、临床 和研究经验，以及必要的创新思想，以支持业务和效率的 网络 作为网络的CC，DCRI将支持以下具体目标：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， 建立可靠和有效的沟通结构，2）提供思想领导和业务 支持试验设计和方案制定，包括相关临床终点的确定， 适当的研究样本量，随机化策略，以及经济和质量的发展， 生命终点，3）制定网络程序手册，提供学习培训和认证 所有临床中心的人员，进行现场监测和开发性能跟踪器，并协调 分包包括所有财务和法律的安排，4）建立财务报销模式 这将促进网络研究的招募;管理并向临床中心分发方案资金， 核心实验室和其他供应商，5）开发和管理电子数据采集系统，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， 确定适当的分析方法、中期分析的时间和 兴趣，7）为所有研究出版物提供编辑，技术和行政支持，并与 指导委员会有效地传达HFN研究的结果。 相关性（参见说明）： DCRI将支持心力衰竭临床试验的进一步创新， 在接下来的七年里进行了一系列具有里程碑意义的试验。这些试验将改变专业准则， 为适当的大型结局试验提供必要的II期数据，并最终改善临床 心力衰竭患者的护理。

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.