EU health regulator clears use of AI tool in fatty liver disease trials
The condition, called metabolic dysfunction-associated
steatohepatitis, or MASH, is a difficult-to-treat disease that
affects around 1.5% to 6.5% of adults in the U.S., according to
the
The AI-based AIM-NASH tool employs a machine learning model trained on more than 100,000 annotations from 59 pathologists who assessed over 5,000 liver biopsies across nine large clinical trials.
The EMA's human medicines committee (CHMP) said evidence showed the AI tool can reliably determine disease activity from biopsies with less variability than the current standard in trials that rely on a consensus of three pathologists.
On that basis, the CHMP concluded, it can accept evidence generated by the tool as scientifically valid, which will help researchers obtain clearer evidence on the benefits of new treatments in clinical trials.
Currently,
Drugmakers such as Novo Nordisk and
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