S3-E41.3 – Improving NASH Clinical Trials By Reducing Screen Fail Rates

S3-E41.3 - 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.

Stephen Harrison starts this conversation by shifting from the issue of inclusion and exclusion to the challenge in finding patients. He points out that while there are millions of NASH patients available in the US alone, only a small percentage of these can actually access trials. This is not only an issue of rural areas. He points out that the number of patients in Chicago enrolled in trials is minimal, despite the large population and high levels of metabolic disease in the Chicago area. He identifies this as a both a weakness in the current system and an opportunity going forward.

Jörn Schattenberg states that while one might assume the more socialized, government-centered systems in Europe would not have this issue, that assumption would be wrong. After a comment about stimulus-response psychology and the impact of screen fail rates on recruiter motivation, I suggest that the US system might be better equipped to address this problem due to higher investment and broader distribution of medical technologies.

I then ask Stephen to explain how mid-trial reassessment of screening criteria works and why it improves screen fail rates. His answer takes up the rest of this conversation.

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