The EMA released its final favorable qualification opinion providing a regulatory framework for the application of the TwinRCT™ solution in Phase 2 and 3 clinical trials. The three-step PROCOVA™ procedure 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.
In their final opinion, the EMA stated that the Committee for Medicinal Products for Human Use (CHMP) “qualifies PROCOVA” and that “the proposed procedures could enable increases in power and/or decreases in sample size in phase 2 and 3 clinical trials with continuous outcomes.” The EMA’s validation of Unlearn’s cutting-edge technology signifies broader regulatory acceptance of AI in clinical development.
You can read more here.
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
- No official support by any organization(s) has been provided or should be inferred
