Clinical Trial Modernization, Digital Health, and AI Evidence Governance

Decentralized models, teletherapy, AI monitoring, ICH E6(R3), Bayesian bridging, registries, real-world data, adaptive designs, and nurse- or mobile-enabled implementation are reshaping evidence generation. New work emphasizes that diagnostic and AI value depends on management change and outcomes, while fine-tuning can increase memorization and privacy-leakage risks; FDA AI oversight and cybersecurity proposals and AMA's 2027 AI-related CPT additions do not establish clinical benefit. FDA comments on its generative-AI discussion paper are due October 19, 2026.