AI‑Enabled RWE at a Crossroads, From Risk Prediction to Decision Grade Evidence
- Applying AI and machine learning to real‑world data to improve risk prediction, safety signal detection, and benefit–risk assessment across development and post‑marketing
- Understanding why AI‑driven analyses often fail to translate into trusted evidence, particularly when uncertainty, bias, or poor contextualization limit interpretation in regulatory and safety settings
- Aligning AI‑enabled RWE with epidemiological principles and regulatory expectations to ensure outputs are interpretable, credible, and decision‑relevant