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.
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.
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