On September 20, 2022, the European Medicines Agency (EMA) qualified Unlearn's patent-pending procedure to leverage historical data and machine learning to reduce sample sizes or increase power in pivotal trials using patient-specific prognostic scores without creating bias. The adopted qualification opinion focuses on our 3-step PROCOVA™ procedure, which provides the regulatory framework for planning and conducting a Phase 2 or Phase 3 TwinRCT™, the novel randomized trial enhanced with participant digital twins.
The adopted qualification opinion was published including links to a handbook for the target trial statistician and two other documents that were part of the review process with Committee for Medicinal Products for Human Use (CHMP). The four documents collectively are 62 pages long. Thus, the purpose of this document is to (1) direct the reader to the most important sections of the qualification opinion, (2) to give a brief overview of the critical elements of the PROCOVA™ procedure, and (3) to address FAQs about the opinion and the supporting documents.