Event Title

An Analysis and Outcomes Report Involving Prescreening Protocol Adjustments in a NASH (Non-Alcoholic Steatohepatitis) Population

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Anna H.T. Nguyen
Jovanna M. Arce

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Sarasota

Mentor Information

Dr. Guy Neff

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NASH clinical trial screenings are wrought with unpredictable barriers to randomization. Herein, we communicate the results of institutional adjustments to screening criteria in order to further distinguish the less NASH-endemic cross-sections of the population from those populations for which consensus labels "high-risk." Current global analyses reveal that less than ten percent of trial candidates achieve randomization; the vast majority of attrition derived from those deemed "high-risk". This exposes a fundamental misattribution established by the current analytic epidemiology of NASH. To pinpoint the absolute lower limits of the disease state, we instituted increased screening thresholds in three biomarkers determined as crucial in NASH patient identification.

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An Analysis and Outcomes Report Involving Prescreening Protocol Adjustments in a NASH (Non-Alcoholic Steatohepatitis) Population

NASH clinical trial screenings are wrought with unpredictable barriers to randomization. Herein, we communicate the results of institutional adjustments to screening criteria in order to further distinguish the less NASH-endemic cross-sections of the population from those populations for which consensus labels "high-risk." Current global analyses reveal that less than ten percent of trial candidates achieve randomization; the vast majority of attrition derived from those deemed "high-risk". This exposes a fundamental misattribution established by the current analytic epidemiology of NASH. To pinpoint the absolute lower limits of the disease state, we instituted increased screening thresholds in three biomarkers determined as crucial in NASH patient identification.