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

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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.

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