Exciting Phase 2b results over the last few months will increase demand for patients to include in NASH clinical trials. So will the recent FDA white paper and webcast, which focused on larger populations for safety evaluation. This week, SurfingNASH discusses why finding these patients will require focus, discipline and perhaps a new way of thinking about trial recruitment.
Drs. Naim Alkhouri and Rashmee Patil join the Surfers to explore this issue. This section explores the reasons it is fallacy to believe there are “plenty of patients” to fill clinical trial slots. Naim, Rashmee and Stephen (all of whom are intimately engaged in patient recruitment for NASH trials) explain the process whereby a high-performing center can screen 10,000 patients in a year and find 150 (best case) who will qualify. A fast-moving and highly informative but somewhat sobering discussion.