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Boosting Reliability: EMA Backs AI Tool For MASH Trials

 
• By Neena Brizmohun

An artificial intelligence-based pathology tool for metabolic dysfunction-associated steatohepatitis shows promise for a drug development landscape that is said to be “fraught with trials that have shown borderline results or outright failures based on liver histology.”

Medicine woman doctor touching digital medical record tablet with Liver. AR of healthcare and network
An AI tool could help with histologic endpoint assessment in MASH trials (Shutterstock)
Key Takeaways
  • The European Medicines Agency has issued a draft qualification opinion recommending the use of an AI-based pathology tool in clinical trials of drugs for metabolic dysfunction-associated steatohepatitis (MASH).
  • The AI tool is expected to be more accurate and reproducible compared with the current method that pathologists use in MASH trials.

The European Medicines Agency is seeking feedback on the use of an artificial intelligence (AI)-based pathology tool that could provide a more reliable assessment of investigational

The AI measurement (AIM) tool, developed by PathAI, could be used in MASH clinical trials to help pathologists in “scoring liver biopsies at enrolment and follow-up visits,” according to a

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