This episode From the Vault follows Season 2, Episode 43 in discussing the possible role of NASH cirrhosis clinical trials in the transition from biopsy as gold standard to a post-biopsy world.
Terns Pharma CEO Sen Sundaram joins this conversation from the audience to ask whether the term “cirrhosis” is medically helpful or might warrant replacement with “end stage liver disease.” After vigorous discussion on this point, Sen departs and Stephen Harrison leads the group through a review of four ongoing NASH cirrhosis trials. The discussion veers into the issue of which analytics methods designers are specifying and why. At one point, Naim Alkhouri, frequent guest and principal investigator on the Gilead combination agent trial, comments before the session ends. His specific contribution: MRE was not included in the Gilead trial largely for cost reasons.
The most striking fact to emerge from this conversation relates to the “beyond the biopsy” question. MRE is emerging as a highly reliable NIT that appears to produce reliable results regardless of mode of action and is generating correlations and ratios to fibrosis level decreases and other key metrics, yet it is not included in the designs of any ongoing NASH cirrhosis trial. Stephen describes this as the “stovepiping” of data. Companies consider the data they need, not ways it can be aggregated with other trials to solve larger issues. This issue bears further exploration in later episodes.