The European Medicines Agency (EMA) offered a positive opinion last week on a new artificial intelligence (AI)–based tool that supports pathologists in diagnosing and assessing the severity of metabolic dysfunction–associated steatohepatitis (MASH) during clinical trials.
This is the first “qualification opinion” by the EMA’s human medicines committee (Committee for Medicinal Products for Human Use [CHMP]) on an innovative development methodology based on AI. It means that the committee can now accept evidence generated by the tool as scientifically valid in future applications and assessments for new MASH treatments.
MASH is a condition where fat builds up in the liver, causing inflammation, irritation and scarring over time, without significant alcohol use or other reasons for liver injury. MASH is linked to obesity, type 2 diabetes, high blood pressure, abnormal cholesterol, and belly fat. If untreated, it can lead to advanced liver disease.
The AIM-NASH tool is expected to enhance the reliability and efficiency of clinical trials for new MASH treatments by reducing variability in measuring disease activity (inflammation and fibrosis).
The CHMP has now issued its first Qualification Opinion (QO) for an AI, agreeing after a public consultation that the AI can increase reproducibility and repeatability in assessments for new MASH treatments, drawing on data from clinical validation study comparing AIM-MASH AI Assist to individual pathologist readings.
That means in turn that it could enhance the reliability and efficiency of clinical trials for new MASH treatments by reducing variability in measuring disease activity and – in theory, at least – lead to treatments becoming available to patients more quickly.
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