ACT Brief: Execution Failures and Upstream Origins, European Data Governance Reshaping CROs, and Phase-Dependent Trial Competition

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

• In part four of her interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explained why execution failures surface where they are visible but originate where conditions were set. Clinical operations leaders too often inherit problems created upstream in protocol design and governance structures, inheriting accountability for failures they had no hand in creating.
• In a new contributed article, ICON examined how the European Health Data Space, adopted by the EU in March 2025, reshapes CRO roles from data custodians to authorized users within regulated processing environments governed by Health Data Access Bodies. This transition creates strategic opportunities for pan-European studies and enables CROs to position themselves as trusted partners delivering regulator-ready real-world evidence at scale.
• In a Pharmaceutical Executive interview, Dr. Richard Graham, chairman and co-founder of TruTechnologies, clarified that the US competes with Australia for Phase I trials but with China for later-stage development, where state coordination and large treatment-naive patient pools drive faster execution. Graham argued that Project TrialBlazer misses the core problem: US clinical trial stakeholders lack alignment on shared goals.

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