AFCRO 2025 Conference
Presentation at the AFCRO 2025 congress on methodological approaches to AI in clinical trials. Synthetic control arms and deployment conditions within a demanding regulatory framework.
AI deployment in clinical trials operates within a rapidly evolving regulatory framework: MDR, EU AI Act, and evolving ICH guidelines. The presentation positions synthetic data not as a methodological shortcut, but as a complementary tool subject to the same validation requirements as classical approaches.
Presentation of the concept of external control arms built from validated synthetic data. Acceptability conditions, validation metrics (statistical fidelity, predictive utility), and use cases where this approach provides demonstrable added value — particularly in precision oncology for rare populations.
First operational results from the TweenMe platform applied to clinical synthetic population generation, laying the groundwork for the OCTOPUS study presented at AFCRO 2026.