Whitepaper

How to position clinical trials with digital twins for regulatory success

This guide provides a framework for successfully incorporating participants' digital twins in clinical trials. Specifically, Unlearn's regulatory-qualified Prognostic Covariate Adjustment (PROCOVA™) methodology can be used to borrow information from AI-generated forecasts of participants' clinical outcomes (i.e., their "digital twins"). These methods enable the design of highly powered studies that use smaller control groups than traditional study designs without introducing bias from external data sources.