S3-E41.4 – Improving NASH Clinical Trials By Reducing Screen Fail Rates

S3-E41.4 - Improving NASH Clinical Trials By Reducing Screen Fail Rates
The "Band" (Jörn Schattenberg, Stephen Harrison, Louise Campbell and Roger Green) gets back together with no other guests to talk NASH Clinical Trials, improving screen fail rates, finding more patients and, generally, what has changed since Jörn co-authored his 2020 article on the NASH Clinical Trial Graveyard.

THE NASH Tsunami audience came to know Jörn Schattenberg in the Fall of 2020 when he shared a paper he had recently co-authored on why NASH drug trials failed. This week, the same group that discussed that paper – Jörn, Stephen Harrison, Louise Campbell and Roger Green – reflect on what has improved in the intervening time period and what has not. The group suggest that researchers are making progress in reducing screen fail rates, but not in the critical issues of accessibility and equity.

Improving NASH Clinical Trials By Reducing Screen Fail Rates

This conversation starts with Jörn Schattenberg asking whether these new, more focused approaches might lead to investigators overfitting patients. He notes the flip side of the issue, which is that we are looking for sweet spot patients that will respond to drug. Louise points out another issue: we encourage patients to improve through healthier lifestyle, but those who do so may no longer qualify for trials. From there, the question shifts to the need to expand the inbound patient funnel appropriately, which involves expanding study of underserved racial and ethnic groups. As Stephen points out, we treat too many patients of similar backgrounds and assume the drug will work for everyone even though we all know that importance of gene differences in disease etiology and outcomes. In the later part of this conversation, Stephen describes what a broad outreach effort might look like.

Sponsoring partnerships with SurfingMASH present a multifaceted avenue for companies seeking to amplify their brand presence and engage with targeted audiences.

Sponsoring Partnerships!

Sponsoring partnerships with SurfingMASH present a multifaceted avenue for companies seeking to amplify their brand presence and engage with targeted audiences.