NASH PASS®: A Registry To Inform Study Design And Accelerate Patient Enrollment

Publication Authors:

Alejandra Macias, Heidi Guthrie, Michelle Mazuranic, and Marcus Hompesch

Presented at The European Association for the Study of the Liver (EASL) Non-alcoholic Fatty Liver Disease (NAFLD) Summit 2022, September 2022

Despite the reported high prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) in the US, trials have challenges with slow enrollment. The aim of the NASH PASS (NASH patient access and screening strategies) registry is to provide a platform to model study design criteria in a community-based population to favourably accelerate clinical development programs. ProSciento’s experience applying this model has resulted in expedited study start-up of interventional clinical trials by more than 1 month on average, reduced screen failures by 15-30%, and increased enrolment rate to more than double compared to industry average.