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NASH patient access

NASH Patient Access

Patient Access and Screening Strategies for NASH Clinical Research

Study participant identification and recruitment continue to be significant challenges in NASH clinical research, impacting cost and timelines.

Many clients utilize ProSciento’s pre-screening to identify patients with steatosis or steatohepatitis using a noninvasive methodology combining vibration controlled transient elastography (VCTE) FibroScan, proprietary clinical algorithms and metabolomic testing. The pre-screening program increases efficiencies by identifying patients that are highly probable to meet recruitment criteria prior to utilizing imaging techniques or biopsies, thereby reducing screen failure rates and avoiding unnecessary invasive and expensive procedures in the enrollment phase of NASH clinical trials.

ProSciento’s Proprietary Pre-Screening Program:

ProSciento’s patient pre-screening, summarized visually below, is a method to identify patients with NAFLD and NASH prior to imaging or biopsies. Clients may choose to utilize this program to increase enrollment efficiencies at clinical research sites.

Click each for a step-by-step description of the patient pre-screening program.

The first step utilizes a methodology combining vibration controlled transient elastography (VCTE) FibroScan and proprietary clinical algorithms to rapidly screen many patients to identify those with steatosis or steatohepatitis.
A secondary filter utilizes metabolomic-based, noninvasive testing to further differentiate those patients with probable steatosis or steatohepatitis.
The result is a targeted subset of patients, pre-identified with probable steatosis or steatohepatitis, to undergo specialized imaging and/or biopsy per protocol to determine clinical trial eligibility.
The resulting outcome is significantly reduced screening failure rates and improved enrollment timelines and efficiencies.