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’s comment that researchers are not always part of specific inclusion or exclusion criteria, but among the tools that more experienced researchers use to improve screen fail rates and matching patients to the trials for drugs most likely to help them. Stephen Harrison notes that metabolic risk factors are among the elements he uses to match patients to trials.
The conversation shifts to focus on factors that aid recruitment. Stephen Harrison contrasts the energy recruiters show when recruiting two trials for the same drug – one in obesity and another in NASH. The obesity trial has a 25% screen fail rate while the NASH trial has an 80% rate. Needless to say, the energy around recruiting the obesity trial is far higher.
Stephen goes on to discuss how earlier errors in trial design – mostly around pathology and biopsy reads – have cost some good drugs their chances for approval. The errors reflected challenges caused by having a single pathology reader and has led to all trials incorporating consensus reads from multiple pathologists.
As the conversation ends, Louise Campbell and Stephen discuss issues around setting inclusion thresholds and how they might vary from trial to trial.