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|May 22, 2026
ACT Brief: RBQM and AI Integration, Statistician Role in Data Stewardship, and Oncology Regulatory Navigation
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine operational RBQM enhanced by AI, how statisticians ensure responsible data use across development phases, and navigating oncology regulation after FDA leadership transitions.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In a new contributed
article , Ken McFarlane of CluePoints outlined how operational RBQM requires cross-functional alignment, proper process assessment, and AI-enhanced data management to replace legacy monitoring with targeted, risk-based approaches. Intelligent query detection, medical coding accuracy up to 99%, and consolidated medical review platforms enable earlier issue detection and audit-ready compliance aligned with ICH E6(R3) and E8(R1). - In part two of her video
interview , Sam Hinsley, statistics manager at Phastar, explained how statisticians can ensure patient data is used responsibly and innovatively across rare disease, personalized medicine, and AI applications throughout development. - In a new
interview from Pharmaceutical Executive, Harpreet Singh, MD, chief medical officer at Precision for Medicine and former FDA Oncology Division Director, emphasized that navigating FDA regulation is "much more facile" with inside knowledge. Singh stresses early and frequent agency engagement, tracking regulatory precedent, and understanding individual division nuances, noting the FDA is data-driven but "not a monolith."
That's all for today's ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.
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