Liver Forum Working Groups

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For more information or to join a working group, contact Brenda Rodriguez at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Active Working Groups:
  • Pediatric Issues: this group is exploring the unique challenges of drug development in pediatric populations. In particular, this group has been looking at the natural history of the disease in children, clinical trials, and ethical issues associated with obtaining informed consent. The working group is led by by Stavra Xanthakos (Cincinnati Children's Hospital Medical Center).
  • Estimands in NASH Clinical Trials: this group is working to bring clarity to the complex topic of defining estimands for Phase 2b/3 NASH clinical trials by addressing topics that include: determining intercurrent events for intermediate and long-term outcomes; defining endpoints for intermediate and long-term outcomes; best practices for summarizing endpoints in each study; establishing recommendations for dropouts and/or missing data. The working group is led by Dr. Peter Mesenbrink (Novartis Pharmaceuticals) and Dr. Veronica Miller (The Forum for Collaborative Research).
  • Standard of Care, Lifestyle Management: this group is working to establish recommendations to standardize how to capture parameters of physical activity and diet for NAFLD/NASH patients in clinical trials and is being led by Dr. Manal Abdelmalek (Duke University) and Dr. Sven Francque (University of Antwerp).
  • Standard of Care, Comorbidity Management: this group is working to develop recommendations for the optimal management of co-morbitities in NASH clinical trials and is being led by Dr. Vlad Ratziu (Université Pierre et Marie Curie & Hôpital Pitié Salpêtrière) and Dr. Raluca Pais (Hôpital Pitié Salpêtrière)
  • NASH Cirrhosis: this group is working on topics including how to define the population of interest, inclusion and exclusion criteria, and how to measure endpoints, and is divided into two subgroups, 1.) Compensated NASH Cirrhosis, and 2.) Decompensated NASH Cirrhosis. The group is led by Dr. Naga Chalasani (Indiana University) and Dr. Arun Sanyal (Virginia Commonwealth University). 
Completed Working Groups:
  • Data Standardization: this group worked to develop recommendations for standardized baseline data collection to facilitate cross-study comparisons and was co-chaired by Drs. Joanne Imperial (Conatus Pharmaceuticals) and Andrew Muir (Duke University Medical Center). The group has published a manuscript and is now completed.
  • Case Definitions: this group worked to create common and standardized definitions of disease stages for patients, summarizing the current state of the science to define disease stages, with concerns, pitfalls, and gaps. The group was co-chaired by Drs. Stephen Harrison (Pinnacle Clinical Research) and Sophie Megnien (Summit Clinical Research). The group has published two manuscripts and is now completed.