European Medicines Agency Qualifies Unlearn’s AI-powered Method for Running Smaller, Faster Clinical Trials

PROCOVA procedure outlines a clear regulatory-qualified framework for implementing AI-generated prognostic digital twins in clinical trials

SAN FRANCISCO--(BUSINESS WIRE)--Unlearn®, the only artificial intelligence (AI) company developing prognostic digital twins to run smaller, faster clinical trials, today announced that the European Medicines Agency (EMA) has released its final favorable qualification opinion providing a regulatory framework for the application of the company’s TwinRCT™ solution in Phase 2 and 3 clinical trials. The three-step PROCOVA™ procedure (patent-pending) is the foundation for TwinRCTs and describes how to use patient-specific prognostic scores derived from digital twins to reduce clinical trial sizes while controlling Type-1 error rates. This qualification opinion represents the first time a regulatory body has formally supported a machine learning-based method for reducing sample size in pivotal trials.

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