Research Article Details

Article ID: A17043
PMID: 28032901
Source: Clin Pharmacol Ther
Title: Structure of proof of concept studies that precede a nonalcoholic steatohepatitis development program.
Abstract: Surrogate endpoints for clinical proof of concept (POC) trials in nonalcoholic steatohepatitis (NASH) are based upon expert pathological review of liver biopsies. During early development, these long-term POC studies (≥48 weeks) add cost and time to the "Go/No Go" decision process. However, it is possible to conduct short-term noninvasive POC studies utilizing biomarkers and magnetic resonance imaging. Here, we discuss the use of shorter noninvasive POC studies relative to biopsy-driven studies for drug development in NASH.
DOI: 10.1002/cpt.560

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