In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.
News|Podcasts|September 10, 2026
ACT Brief: Explainable AI for Patient Subgroups, Participant Understanding and Engagement, and FDA Leadership Stabilization
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine why black-box AI fails in clinical trials, how participant understanding drives engagement more than gamification, and FDA permanent leadership appointments prioritizing regulatory predictability.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In the
latest Beyond Compliance episode , Joseph Geraci, PhD, co-founder and chief scientific and technical officer at NetraMark, explained why black-box AI models are poorly suited to clinical trial data where regulators and clinicians need to understand how conclusions were reached. Explainable AI capable of recognizing when it lacks sufficient information surfaces clinically meaningful patient subgroups characterized by variables clinicians can recognize and act on, allowing insights from earlier phases to inform later trials. - In a
new contributed article , Aubrey Verna of YPrime examined how participant engagement depends far more on clarity and understanding than on gamification or incentives. Survey data showed 46% of participants identified better understanding of trial importance as the single most impactful engagement factor, far exceeding recognition (39%) and reminders (37%), suggesting engagement must be embedded into trial workflows as a core design element. - The
FDA announced four permanent senior leadership appointments , confirming Michael Davis, MD, PhD, as director of CDER and Karim Mikhail, BPharm, MSc, as director of CBER, while also creating the agency's first-ever Deputy Commissioner for Technology and AI role. Placing AI governance at the deputy commissioner level signals the administration intends AI oversight to be a cross-agency priority, while the center appointments address structural uncertainty that has constrained biotech deal flow and IPO activity throughout 2026.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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