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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10HL080413-05S1
Application #
8720867
Study Section
Special Emphasis Panel (ZHL1-CSR-M (F1))
Program Officer
Reynolds, Herbert Y
Project Start
2009-05-01
Project End
2014-04-30
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
5
Fiscal Year
2013
Total Cost
$445,000
Indirect Cost
Name
Duke University
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
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Durheim, Michael T; Collard, Harold R; Roberts, Rhonda S et al. (2015) Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med 3:388-96
Collard, Harold R; Brown, Kevin K; Martinez, Fernando J et al. (2014) Study design implications of death and hospitalization as end points in idiopathic pulmonary fibrosis. Chest 146:1256-62
Swigris, Jeffrey J; Streiner, David L; Brown, Kevin K et al. (2014) Assessing exertional dyspnea in patients with idiopathic pulmonary fibrosis. Respir Med 108:181-8
Idiopathic Pulmonary Fibrosis Clinical Research Network; Martinez, Fernando J; de Andrade, Joao A et al. (2014) Randomized trial of acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med 370:2093-101
Han, MeiLan K; Bach, David S; Hagan, Peter G et al. (2013) Sildenafil preserves exercise capacity in patients with idiopathic pulmonary fibrosis and right-sided ventricular dysfunction. Chest 143:1699-708
Idiopathic Pulmonary Fibrosis Clinical Research Network; Raghu, Ganesh; Anstrom, Kevin J et al. (2012) Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis. N Engl J Med 366:1968-77
Noth, Imre; Anstrom, Kevin J; Calvert, Sara Bristol et al. (2012) A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 186:88-95
Swigris, Jeffrey J; Han, Meilan; Vij, Rekha et al. (2012) The UCSD shortness of breath questionnaire has longitudinal construct validity in idiopathic pulmonary fibrosis. Respir Med 106:1447-55

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