ACT Brief: AI Impact Faces Reality Check, Supply Chain Risks Intensify, and RWE Shapes Global Strategy

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part four of his video interview, Mark Freitas of Alvarez & Marsal offered a measured view of AI’s role in clinical trials, noting that while it is accelerating upstream protocol development, clear evidence linking it to faster approvals and patient impact remains limited.
• A new Q&A with Hal Green of Loftware highlights how geopolitical instability is pushing clinical supply chains from an efficiency focus to a resilience imperative. As global disruptions become the norm, fragmented data and disconnected systems are emerging as key points of failure, with sponsors now prioritizing real-time visibility, adaptability, and continuity to prevent cascading delays and protect trial integrity.
• At Asembia's AXS26 Summit, Tommy Brammley of Cencora discussed how expanding FDA support for real-world evidence is shaping global launch strategies. Building on the 21st Century Cures Act, regulators in the US and Europe are increasingly accepting RWE, though data quality and methodology remain critical to ensure submissions are fit for purpose and free from bias.

That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.