---
title: >-
  Validation of a Clinical Risk-based Classification System in a Large
  Nonalcoholic Fatty Liver Disease Real-world Cohort.
description: >-
  Explore this publication on real-world evidence: Validation of a Clinical
  Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease…
date: '2023-01-01'
category: Publications
tags:
  - Clinical Gastroenterology & Hepatology
  - Abstract / Manuscript
  - Approval / Commercialization
  - Care
  - Hepatology
  - MASH/MASLD
  - Health System Partner
canonical_url: >-
  https://www.pedestalhealth.com/resources/publications/cgh-journal/validation-of-a-clinical-risk-based-classification-system/
source: Pedestal Health
license: © 2026 Pedestal Health. All rights reserved.
slug: validation-of-a-clinical-risk-based-classification-system
id: 2olzN0mSACJgYomXowWioG
contentType: article
---

## Challenge

Histological fibrosis staging by liver biopsy is invasive, impractical at scale, and inaccessible in community settings, yet drug developers and clinicians lacked a validated, biopsy-free prognostic system that could stratify NAFLD patients by mortality and clinical event risk using widely available data.

## Solution

The TARGET-NASH longitudinal real-world cohort was used to validate a pragmatic, FIB-4- and clinical criteria-based risk classification system against hard outcomes—mortality, liver events, and MACE—across a large, diverse US population spanning academic and community sites.

## Impact

Providing a validated three-tiered prognostic classification applicable universally, without biopsy, equips drug developers with a scalable patient stratification tool for trial enrollment and supports regulatory endpoints grounded in real-world clinical outcomes.

### [Breda Munoz](/people/breda-munoz/)

![Breda Munoz, PhD — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/3H1T2mfvSNFj6w9tulnreq/a74ae05fe53e400f176d4e9c617b8fb8/breda-munoz.jpg)

### [Andrea R. Mospan](/people/andrea-mospan/)

![Andrea R. Mospan, PhD, RAC — Profile Photo](https://images.ctfassets.net/h4s3ip99qawo/4w6bkwPHPqrXKYs4tHZPkK/1d21763b54ecc3466764986693b7072f/andrea-mospan.jpg)