The National Heart, Lung, and Blood Institute (NHLBI) has proposed an initiative to create a Clinical Research Network (CRN) with the goal of efficiently conducting randomized trials to improve clinical outcomes for patients with newly diagnosed idiopathic pulmonary fibrosis (IPF). The CRN will be structured to have 6 to 7 clinical centers and one data coordinating center (DCC). The network will conduct a series of clinical trials evaluating new and established drugs and therapies. The Duke Clinical Research Institute (DCRI) proposes to serve as the DCC for the network. In this role, the DCRI will coordinate and manage the clinical research and organizational activities of the CRN. Using our extensive research experience and infrastructure, we will assist in developing study protocols, monitoring data collection activities, and protocol-specific training of clinical centers. We have assembled a team of experts in biostatistics, pulmonary medicine, health economics, and quality of life to ensure that scientifically defensible and clinically meaningful conclusions can be drawn. We will promote the progress of the CRN through a wide variety of interfaces including web-based technologies, national pulmonary and health outcomes meetings, and scientific publications. To achieve the objectives of the IPF-CRN, the DCRI will focus on the following activities: (1) study coordination and planning, (2) data management and reporting activities, (3) trial design and protocol development, (4) data analysis, and (5) publication and dissemination of results.
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