In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
News|Podcasts|June 2, 2026
ACT Brief: Process Architecture Over Autonomous AI, Real-Time RWE Integration, and Building RWE Infrastructure
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine why process architecture matters more than autonomous agentic AI, shifting RWE from post-approval to concurrent validation, and organizational capabilities needed for effective RWE use.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In part three of his video
interview , Abraham Gutman shared key takeaways from a presentation he gave at SCOPE X, including a pointed caution against the idea that agentic AI can run clinical trials autonomously. Gutman emphasized that process architecture is the real entry point for AI to deliver on its promise, not autonomous decision-making. - In a new contributed
article , Christopher Boone of Oracle examined how real-world evidence is shifting from a post-market footnote to concurrent validation running alongside trial data. Organizations furthest along have built unified data environments integrating EHRs, claims, and patient-reported outcomes as complementary inputs into a single evidentiary framework, enabling early signal detection rather than late-stage course corrections. - In a new
FAQ article, as the FDA formally recognizes RWE as eligible confirmatory evidence, sponsors face growing imperative to build data infrastructure and analytical capabilities for effective RWE use across the development lifecycle. The concurrent validation model fundamentally changes the nature of regulatory conversations by stress-testing evidence from multiple directions before approval.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
Related to this article
In today’s ACT Brief, we examine how AI is moving into continuous clinical operating models, how trust is built into oncology real-world evidence, and how the FDA approved a self-administered option for thyroid eye disease.
In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
In Episode 3 of The Human Side of Clinical Trials, hosts Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., speak with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about why a well-written protocol doesn’t always translate into consistent execution, and how designing for the way people actually think and learn can reduce site burden and the need for costly unlearning.
In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug development, and why oncology real-world evidence still faces persistent data barriers.
In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.
Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
Clinical trials capture data faster than ever, but the real bottleneck is the distance between data capture and a decision teams can trust.
Trending on Applied Clinical Trials Online
1
Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology
2
Bipartisan Bill Would Build Reusable Clinical Trial Networks, With a Focus on Rare Disease
3
Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
4
ACT Brief: Orchestrated AI Clinical Environments, eSource Coordinator Satisfaction, and Faster Clinical Trials Act
5