ACT Brief: Trust in Clinical Trial Engagement, Participant Readiness and Adherence, and AI in Regulatory Compliance

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

• In part two of her conversation with ACT EAB member Rebecca Johnson, PhD, Adrelia Allen, executive director of clinical trial patient diversity at Merck, explained how Let's Talk Trials was designed to address awareness and access gaps in clinical trial participation. Allen discussed what differentiates the initiative from earlier efforts and how trust sits at the center of the program's approach to engaging communities.
• In his latest column, Brian McGowan, ACT EAB member, examined why adherence strategies often fail despite digital tools and education. Participant readiness—the combination of knowledge, calibrated confidence, and real-world mastery—determines whether behaviors sustain amid competing demands and disruption. Technology and education support readiness but cannot substitute for it, and sponsors treating adherence as a design problem rather than a technology problem improve outcomes meaningfully.
• In a Q&A from Pharmaceutical Technology, George Kwiecinski, CEO of Global Key Solutions Corp, discussed FDA's rising scrutiny of AI in regulatory and quality workflows. Analysis of FDA correspondence shows five direct regulatory references to AI and over 20 guidance documents mentioning it, with frequency increasing. Organizations using AI in compliance and quality processes must document and defend those decisions risk-based approaches, as FDA inspection focus is shifting toward how AI-assisted decisions are managed and justified.

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