ACT Brief: Data Readiness Gap in Continuous Monitoring, Workflow-Centric AI Deployment, and First-in-Class ADHD Mechanism

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

• In part one of a new interview, Raviv Pryluk, CEO and co-founder of PhaseV, explained why the gap between data collection and analysis-ready data undermines the promise of continuous trial monitoring. Closing this gap requires architectural changes to how data flows from collection through to actionable analysis.
• In a contributed article, Norman Goldfarb examined how AI agents operate only within workflows, but most clinical research organizations lack unified workflow management systems to identify deployment opportunities or ensure integration. Without foundational workflow-centric infrastructure, adding AI agents amplifies existing fragmentation rather than reducing it.
• FDA approved Otsuka's Simtriyo as the first norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD in adults and children 6 years and older weighing at least 20 kg. Phase III trials demonstrated statistically significant improvements in ADHD symptoms by week one across all age groups, with symptom separation from placebo maintained throughout treatment.

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