Committees
Steering Committee
The steering committee comprises the site-PIs (both AUD and ALD) of the clinical centers, the directors of the DCC, and NIAAA. The committee will provide oversight of the trial. The Chair and co-chairs of the steering committee have been selected by the NIAAA. All study committees will be formed by the Steering Committee and will report to it for final decisions. The Committee provides strategic guidance, oversight, and decision-making authority for the clinical trial.
Clinical Subcommittee
The Clinical Subcommittee provides expert guidance on the clinical aspects of the trial to ensure medical relevance, patient safety, and protocol feasibility. Key responsibilities include reviewing and advising on clinical protocol design, inclusion/exclusion criteria, safety monitoring procedures, and standard-of-care considerations. The committee supports site investigators, addresses clinical questions that arise during trial conduct, and ensures that trial interventions are practical and ethically sound within real-world clinical settings. The chair and co-chairs of the Clinical Subcommittee have been selected by NIAAA. This committee will make recommendations and bring them to the full Steering Committee for final decision.
Publication and Ancillary Study Committee
The Publication and Ancillary Study Committee manages the review, approval, and coordination of all publications and ancillary study proposals related to the AlcHepNet studies. Its duties include ensuring consistency with the trial's scientific goals, safeguarding participant confidentiality, maintaining data integrity, and avoiding duplicate or conflicting analyses. The committee assesses proposals for scientific merit, feasibility, and proper use of trial data or biospecimens, while encouraging timely reporting of results and compliance with authorship and publication guidelines.
Chair
Ashwani Singal, MD
Co-chair
David Streem, MD
Member
Richard Sterling, MD
Member
Mack Mitchell, MD
Member
Patrick Kamath, MD
Data Science Committee
The Data Science Committee provides oversight and strategic guidance on all aspects of data management and analysis within the clinical trial. Responsibilities include advising on data collection protocols, ensuring data quality and integrity, reviewing statistical analysis plans, and supporting the integration of advanced analytic methods. The committee also promotes transparency, reproducibility, and adherence to regulatory standards, while facilitating timely and accurate interpretation of trial data to inform clinical and operational decision-making.
