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.

Enter your email address to download paper.

Click the link to begin download.
Oops! Something went wrong while submitting the form.

Enter your email address to watch the webinar.

Click the link to watch webinar.
Oops! Something went wrong while submitting the form.

How will AI transform the future of medicine?

White Papers

Evaluating Digital Twins for Alzheimer’s Disease using Data from a Completed Phase 2 Clinical Trial

White Papers

Prognostic digital twins overcome the limitations of external control arms in RCTs

Both methods reduce control arm sizes, but only digital twins control for bias.
A Phase 2 study on crenezumab in mild-to-moderate AD was used to retrospectively assess the validity of Unlearn's approach for AD clinical trials.
Hear from Charles Fisher, founder and CEO of Unlearn, in this on-demand webinar about how AI will transform the medical landscape of tomorrow.