Designing Clinical Trials for Alcohol-Associated Liver Disease

Description

Tthis community conversation engages clinical researchers at all levels—from trainees to senior investigators—in discussions related to clinical trials involving alcohol-associated liver disease (ALD) and alcohol-associated hepatitis (AH). From design to implementation, this session highlights special considerations such as endpoint selection, development of novel biomarkers, novel clinical trial designs, emerging pharmacotherapies, alcohol consumption during clinical trials, and opportunities in ALD and combined metabolic dysfunction-associated and alcohol-associated liver disease (MetALD). Topics addressed include: (1) selection of appropriate clinical and patient-reported endpoints that consider both clinical relevance and statistical rigor; (2) limitations of traditional biomarkers and emerging novel biomarkers relevant for monitoring and targeting such clinical and patient-reported endpoints;  (3) outcomes specific to liver disease, alcohol use disorder (AUD), and the intersection of ALD and AUD; (4) practical guidance for initiating novel clinical trial designs, including assessment of the environment and necessary resources; (5) strategies to improve subject participation and retention; and 6) emerging interventions with potential for overlap in ALD and MetALD.