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

Send us Fan MailTHE 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. Large metropolises are identified as missed opportunities. Stephen starts this conversation by shifting focus from issues surrounding trial criteria to the challenge of finding the right patients for these trials. He notes that of the millions of patients with NASH in the U.S. today, only a small fraction might ever realistically find their way to a NASH trial. The biggest factor is that they can only find their way to a trial if they live with  clear access to a trial center. This is not simply a question of rural and exurban residents having too far to travel. He cites Chicago as a city that contributes minimal patient enrollment, despite being a large cites whose population  suffers from high levels of metabolic disease. Jörn adds that while we might believe that European countries with more socialized, government-centered systems would not exhibit this maldistribution in where trial patients live, that belief would be wrong. Roger suggests that the U.S. system, with its highest levels of investment in medical technologies and broader distribution of care sites, might actually be better equipped to attack this issue. At that point, Roger returns to an earlier comment to ask Stephen addresses how mid-trial reassessment of screening criteria works and why it improves screen fail rates. Stephen's answer takes up the rest of this conversation.