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S3-E26.3 – Advancing NASH Best Practices In NITs: Optimizing NASH Biomarker Set

Quentin Anstee joins the Surfers (including Stephen Harrison) to discuss two recent presentations on NITs and to explore benefits and best ways to "stack" NASH biomarkers to create a more robust efficacy measure for clinical trials.

This conversation starts with Roger Green asking Quentin Anstee to clarify exactly what he means by “stacking” variables. Quentin’s reply: multiple measures to confirm the same endpoint or result, so that the more measure achieve the target, the more confident we can be that therapy has succeeded. Louise Campbell suggests that this kind of stacking approach might enhance our ability to assess efficacy in diverse populations, given that demographic subpopulations might differ in the way they respond to therapy. The group goes on to discuss the importance of collecting Phase 3 trial results from a broad set of NITs in order to determine the right combination of NITs to use in a stacking equation. The conversation goes on to note the need to standardize fairly quickly to improve our ability to manage the cost and predictiveness of trials and to consider what kinds of tests and metrics will work best in the stacking process.

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