Limited Competition: Alcohol-associated Hepatitis Clinical Network Integrated Treatment Clinical Trials Data Coordinating Center (U24 - Clinical Trial Required)

Funding Opportunity RFA-AA-24-005 from the NIH Guide for Grants and Contracts. he purpose of this limited competition Notice of Funding Opportunity (NOFO) is to support the Data Coordinating Center of the previously funded program on Late Phase Clinical Trials and Observational Studies in Alcoholic Hepatitis. The existing program of AH Clinical and Translational Network, hereafter termed Alcohol-associated Hepatitis Network, AlcHepNet, has been sponsored by the NIAAA since 2012 and was renewed in 2018. The purpose of this research program is to improve biomedical, psychosocial and quality of life outcomes for patients with advanced alcohol-associated liver disease. In the next cycle the program will consist of up to six Clinical Study Sites and one Data Coordinating Center to conduct an integrated treatment clinical trial that incorporates active treatment of AUD with treatment of liver disease. The targeted patient population will include severe alcohol-associated hepatitis (sAH) and decompensated alcohol-associated cirrhosis (deAC). Through this RFA, applications are sought for a Data Coordinating Center (DCC) to provide expert assistance to support the AlcHepNet network-wide common protocol clinical trial and local site ancillary studies on data management, statistical analysis, biospecimen collection, and logistical support under the U24 Resource-Related Research Projects Cooperative Agreements funding mechanism.