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S2-E52.3 – Can MRE Provide Reliable, Non-Invasive Clinical Trial Endpoints?

Alina Allen and Stephen Harrison spearhead a discussion on how MRE results can provide a foundation for developing Subpart H Clinical Trial Endpoints from non-invasive testing data. Their comments stem from Alina's presentation of the recent Mayo Clinic paper, "MRE for Prediction of Long-Term Progression and Outcome in Chronic Liver Disease: A Retrospective Study." In this conversation, Alina summarizes the paper, after which Stephen Harrison asks questions about availability of subgroup analysis.

For NASH to move “beyond the biopsy,” researchers must develop reliable clinical trial endpoints using non-invasive tests. This conversation winds up centering around MRE’s ability to provide those metrics.

It starts with two different points; Ian Rowe comments on the power of the message in dealing with patients. Specifically, he notes that the word “cirrhosis” does not engender strongly emotional or motivating responses whereas the word “cancer” certainly does so. Next, Stephen Harrison asks how cleanly we can translate MRE results into transient elastography readings. Ian suggests the answer is “not very clearnly.”

Then the meat of the conversation starts, as Stephen asks whether MRE and LSM can lead us to a viable Subpart H surrogate endpoint. For this to work, he notes, we would have to translate LSM and/or liver function readings into a metric that then translates into an outcome. Alina Allen notes that MRE has the benefit of producing consistently read results without the reader variability issues we find with biopsy. Stephen pushes further, noting that it would be a major step to link magnitude of effect to a one-level fibrosis change, Alina reveals that the number falls consistently around 19%. Alina notes that we have no similar relationship for MELD scores, but the group agrees in the end it should be possible to design trials around MRE-based outputs.

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