S3-E58.3 - NAIL-NIT Retrospective Analysis and the Role of Consortia in Reshaping the Focus of NITs

Send us Fan MailSurfing the NASH Tsunami begins its year-end series to reflect on a momentous 2022 for NAFLD and Season 3 of the podcast. Leading this final conversation, Roger Green asks Jörn Schattenberg what has surfaced in the past several months with the various consortia, and particularly the retrospective analysis in NAIL-NIT. Jörn starts by commenting that non-invasive testing may have more momentum now than any other areas in research. He notes the increasing number of consortia and the role they play in shaping the scope of NITs. One impact has influenced change in the original focus of how NITs could replace biopsies. The shift explores how NITs can be validated by histology via reductions in ALT, MRI-PDFF and MRE metrics. For particular data of interest, Jörn goes back a year to a study from the NASH CRN that measured severity in terms of baseline histology and then produced ratios of decompensation at different fibrosis stages. He goes on to explain that data from the single-sponsor studies, such as the resmetirom MAESTRO data, produces faster results than the larger consortium studies. Louise Campbell asks whether or how we can measure the impact of patient behavior change on outcomes in these studies. Jörn notes that the researcher can include questionnaires and app-based assessments to accommodate these factors.At the bottom of the hour, Roger asks the group for final thoughts on changes envisioned for the next year specifically in terms of pathways. Each panelist provides thought-provoking responses to presage what is aligned to be another progressive year for the field in 2023.