The National Heart, Lung, and Blood Institute (NHLBI) has proposed an initiative to establish a Heart Failure (HF) Clinical Research Network with the overall goal of accelerating research in the diagnosis, management, and treatment of heart failure, and thereby improving patient outcomes in the rapid growing population of HF patients. The HF Network will be structured to have up to eight regional clinical centers to perform multiple clinical studies and one Data Coordinating Center (DCC). The network will provide the necessary infrastructure to develop, coordinate, and conduct multiple concurrent studies and facilitate the efficient application of emerging basic science discoveries into well-designed clinical investigations. The Duke Clinical Research Institute (DCRI) proposes to serve as the Data Coordinating Center for the HF Network. In this role, the DCRI will coordinate and manage the clinical research and organizational activities of the HF Network. Using our extensive research experience and infrastructure, we will assist in developing study protocols, monitoring data collection activities, providing protocol-specific training of clinical centers, and performing state-of-the-art statistical analyses. We have assembled a team of experts in biostatistics, cardiology (including heart failure), and clinical trials to ensure that scientifically defensible and clinically meaningful conclusions can be drawn. We will promote the progress of the HF Network through a wide-variety of interfaces including web-based technologies, national cardiology and heart failure meetings, and scientific publications. To achieve the objectives of the HF Network, the DCRI will focus on the following activities: (1) study coordination and planning, (2) study design and protocol development, (3) site management, monitoring for quality assurance, and regulatory requirements, (4) data management and reporting activities, (4) statistical data analysis, and (5) publication and dissemination of results. Through its vast experience in coordinating other cardiology and heart failure trials, and through the services it will provide to the HF Network, the DCRI as the DCC will be a vital resource in the successful establishment of this important network.
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