The Liver Meeting 2019-Current Clinical Trials Design: Fresh Look at the Old Problem

Current Clinical Trials Design: Fresh Look at the Old Problem

Video Transcription

Video Summary

The speaker discussed stratification of alcoholic hepatitis (AH) patients into mild, moderate, and severe categories based on Mel's score. They emphasized the need for studies targeting less severe AH cases. Phase two trials with endpoints like liver biopsy for treatment response and Mel's score reduction of five or more at 90 days were proposed. The focus on virtual trials for recruitment using digital media was highlighted to improve efficiency. Adaptive trial designs to plan for failure and transition seamlessly between phases were also discussed. Post-transplant pharmacotherapy for alcohol use disorder and the importance of defining relapse criteria were considered. Lastly, the debate on total abstinence versus moderated drinking after liver transplant was touched upon, aiming for personalized approaches.

Asset Caption

Presenter: Patrick S. Kamath

Keywords

alcoholic hepatitis

Mel's score

phase two trials

liver biopsy

adaptive trial designs

post-transplant pharmacotherapy