Tuesday, September 1, 2020
The level of discordance between pathologists, and the differences in operationalizing liver biopsy collection in trial protocols have been frequently raised as major issues and areas of concern for NASH clinical trials.
The goal of this session was to discuss issues including: inter/intra-observer variability, scoring systems, and technical and logistical considerations.
Materials:
Presentations:
Setting the Stage: Review of Issues and Recent Data
Stephen Harrison, Oxford University
Moderators:
Judith Ertle, Boehringer Ingelheim
Arun Sanyal, Virginia Commonwealth University
Brent Tetri, Saint Louis University
Panelists:
Pierre Bedossa, LiverPat
Cynthia Behling, University of California San Diego
Oscar Cummings, Indiana University
Lara Dimick-Santos, U.S. Food and Drug Administration, CDER
Stephen Harrison, Oxford University
Prakash Jha, U.S. Food and Drug Administration, CDRH
David Kleiner, NIH National Cancer Institute
Massimo Siciliano, Università Cattolica del Sacro Cuore & external AIFA / EMA expert
