Alcoholic hepatitis (AH) is a leading cause of liver-related morbidity and mortality with a remarkable paucity of effective therapeutics. This application for a Data Coordinating Center (DCC) is part of a coordinated submission of several NIAAA-funded consortia that have come together as the Alcoholic Hepatitis Network (AlcHepNet). Collectively, the network will synergize efforts and expertise to better understand AH and develop novel effective and safe therapies for severe AH. The overarching aims of this new consortium are to: 1) perform studies to better understand the pathogenesis and main determinants of outcomes, particularly in severe AH; 2) identify novel targets for therapy of AH, and 3) perform phase 2B studies of compounds that are already FDA approved and available and can be repurposed as safe and effective therapies for severe AH. The DCC will be composed of two complementary DCC Units ? one at Indiana University School of Medicine (DCC IU), submitting this application, and one at the University of Massachusetts Medical School (DCC UMMS), submitting the companion application. Due to the complexity and breadth of studies and responsibilities of the combined DCC in the AlcHepNet, the dual-DCC structure will provide the statistical and data management leadership to multiple studies, including network-wide studies, multiple pilot randomized clinical trials (RCTs) and translational studies, using innovations based on previous experience to facilitate the operations of these studies and supporting the highest quality reproducible research.
The aims of the dual DCC are: 1) Efficient and Effective Network Management through development of a robust shared infrastructure including communication support and administrative services to facilitate AlcHepNet objectives. 2) Provide high-level leadership to the scientific methodology of the AlcHepNet, especially in the areas of study design, data management and statistical analysis. 3) High Quality Study Implementation to ensure high quality, reproducible study results through a rigorous program of quality assurance and control, study monitoring and DSMB and regulatory reporting. DCC IU will be responsible for the two nine-center studies, a longitudinal observational study of AH patients and heavy drinking controls and a three arm late phase clinical trial. By testing promising therapies for AH and collecting well-annotated patient samples and datasets, the DCC for the AlcHeoNet will have a strong and lasting impact on the field.
The Alcoholic Hepatitis Network, AlcHepNet, comprised of nine leading partner institutions in the field, will examine new and promising treatments for severe liver damage caused by alcohol. Further, the Data Coordinating Centers will collect and organize patient information, associated data, and samples that can help shed greater light on this disease. Combined, these two approaches will improve treatment and how we care for patients with this devastating liver condition.