The European Medicines Agency (EMA) has issued its first Qualification Opinion (QO) on an AI-based tool for clinical research. The tool, AIM-NASH, assists pathologists in analysing liver biopsies to assess the severity of MASH (Metabolic dysfunction-associated steatohepatitis) in clinical trials. This means that the EMA’s human medicines committee (CHMP) has recognised AIM-NASH as a valid method for evaluating inflammation and fibrosis in MASH disease with less variability than the current standard used in clinical trials, which relies on a consensus by three independent pathologists.

The tool is expected to improve reliability and efficiency in clinical trials by reducing variability in biopsy assessments, ultimately accelerating the development of new MASH treatments.

This first QO on an AI-based system  marks a significant step towards the integration of artificial intelligence into clinical research. To ensure the safe and effective implementation of these technologies, ongoing interaction with regulatory authorities is essential, as they are actively developing strategies to promote the safe and responsible use of AI in medicine development. Regulatory engagement not only facilitates the adoption of such innovations but also ensures that patient benefits are maximised while maintaining high safety standards.

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