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S3-E14.4 – Ballooned Hepatocyte Analysis and Reassessing Drug Development

This Episode is Sponsored By HistoIndex: How can a reassessment of the way we analyze ballooned hepatocyte cells in clinical trials reshape drug development practices and the success rates in clinical trials?

One major discussion at NASH-TAG this year was about the inconsistency in ballooned hepatocyte identification and how this inconsistency inflates screen fail rates and possibly placebo response across studies. This conversation is part of a thorough exploration of this issue.

This conversation starts with Roger Green wrapping up the earlier discussion of the relationship between holistic NASH assessment and ballooned hepatocyte scoring by saying it is not surprising that fibrosis is an element in ballooned cell scoring, given that pathologists start with a holistic assessment and work back from there.

Jörn Schattenberg asks Quentin Anstee to comment on Stephen Harrison’s proposal to use 3 slides for H & E reads. After discussing a different strategy (“keep reading until you see enough cells”), Quentin suggests a protocol with a constant, relatively small number of slides for each case. Roger then asks Quentin how many ballooned cells might appear on a single slide; Quentin answers that this is a challenging question but on the slide where everyone saw the most ballooned cells, the number scored by an individual pathologist ranged from 45 to 225. After Louise Campbell comments on the need to make the best possible use of tissue out of respect to the patient who is donating the biopsy, Roger asks a final question: a year or two from now, what is likely to be different and what can we aspire to be different as a result of this study. Quentin would like to see ballooned hepatocyte assessment move from a “Yes/No” assessment to a continuous assessment of volume and would like to see regulators recognize the role and value of AI-assistive technologies in drug development. Mazen Noureddin concurs and goes on to ask what we might expect in terms of changes in the screen fail rate. In different ways and with different nuances, Jörn, Louise and Roger concur as well.

The episode and this conversation are sponsored by HistoIndex. Conversation 14.5 is a discussion of how artificial intelligence driven assistive technology can improve the consistency of ballooned hepatocyte scoring in advanced fibrosis and support development of robust outcomes for fibrosis studies.

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