Heart Failure Clinical Research Network Coordinating Center

国家心肺血液研究所已经征集了继续心力衰竭(HF)的申请 临床研究网络(网络)加速心力衰竭的诊断和治疗研究 通过优化现有疗法的应用和对新疗法的评估，改善患者的预后。 杜克临床研究所(DCRI)建议作为联合数据协调 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，以及支持运行和效率所需的创新想法 网络。 作为网络的CC，DCRI将支持以下具体目标：1)协调总体活动 网络、网络委员会和核心实验室，并与NHLBI和指导委员会合作 建立可靠和高效的沟通结构，2)提供思想领导力和操作能力 支持试验设计和方案制定，包括确定相关的临床终点； 适当的研究样本量、随机化策略以及经济和质量的发展 LIFE终端，3)制定网络程序手册，为学习提供培训和认证 所有临床中心的人员，执行现场监控并开发性能跟踪器，并协调 分包，包括所有财务和法律安排；4)建立财务偿还模式 这将促进网络研究的登记；管理并向临床中心分配方案资金， 核心实验室和其他供应商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， 确定适当的分析方法、中期分析的时间和先验的分组 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，以有效地传达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，使该网络能够完成 在接下来的7年里进行了一些里程碑式的试验。这些试验将改变专业指南，将 提供适当的大结局试验所需的第二阶段数据，并最终改善临床 护理心力衰竭患者。

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.