Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) - Indiana University Data Coordinating Center

Alcohol-associated hepatitis (AH) is primarily driven by alcohol use disorder and is a significant contributor to liver-related morbidity and mortality. Presently, there are no FDA-approved therapies for severe AH. This Data Coordinating Center (DCC) is a part of the Alcohol-associated Hepatitis Network (AlcHepNet), which conducts clinical trials in searching for safe and effective therapies for alcohol-associated liver disease. Collectively, the network will synergize efforts and expertise to develop effective and safe treatments for advanced alcohol- associated liver disease. In the current application, the network proposes to conduct a proof-of-concept randomized controlled trial, the Integrated Therapies for Alcohol-associated Liver Disease (ITAALD), which targets patients with severe AH eligible for steroid treatment by first treating the acute liver injury and then intervening on the underlying alcohol use disorder. The DCC will serve as vital infrastructure for the network, facilitating the execution of the ITAALD trial. The DCC application encompasses four overarching objectives: (1) providing integrated administrative, clinical, and research support for the ITAALD trial; (2) providing efficient and high-quality data management and analytical support; (3) establishing and maintaining the network's biosample repository; and (4) expanding a research data commons established during the previous funding cycle and enhancing its analytical capabilities. By ensuring the faithful implementation of the ITAALD trial, the Indiana University DCC will safeguard the scientific integrity and reproducibility of the trial outcomes. Furthermore, its biorepository and data commons will facilitate the analysis of biospecimens generated by the network, fostering data dissemination within and beyond the AlcHepNet consortium.