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This episode addresses the other talks in Session 5 focusing on clinical trial innovation, after Frank Anania’s opener.

Roy Sabo presented a cogent, comprehensible discussion of the value of adaptive trial strategies. Roger relates the presentation to a conversation on the NASH Tsunami last month with Stephen Harrison. Stephen introduced an example of adjusting FibroScan thresholds to boost the number of patients who could enter clinical trials. Roger commends Sabo on the “wizardry Bayesian statistics.”

The following two talks discussed organizing patient databases in ways that simplified trial recruitment and had the potential to reduce screen fail rates. Lastly, the group explores the pros and cons of educating patients on improving self-care. The benefit is that it creates a larger, ready-made patient pool and improves overall health. The drawback is that it increases placebo rates in clinical trials, thereby requiring drugs to perform better to demonstrate statistical difference. However, in a world of well-informed patients practicing aggressive health self-management, there should be the expectation that drugs offer better performance.

The conversation finishes with covering the rest of the day one program.