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Methodological and regulatory considerations for causal AI in drug development
0
Zitationen
7
Autoren
2026
Jahr
Abstract
Advances in AI offer significant opportunities to enhance drug development. While several regulatory agencies have begun issuing guidance on AI adoption, its application to causal inference-a critical piece to understand treatment effects and inform regulatory decisions-remains limited. This paper reviews regulatory activities and examines statistical methodologies for AI-driven causal inference. We discuss key regulatory challenges and illustrate how AI adds value across diverse data sources and studies.
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