ACT Brief: Community Engagement for Enrollment, Plausible Mechanism Framework Essentials, and AI Scaling Foundations

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

• In part two of his video interview, Del Smith, PhD, CEO and co-founder of Acclinate, outlined what a practical, sustained community engagement framework looks like and how sponsors can translate that investment into faster, more efficient, and more representative enrollment by building genuine partnerships rather than treating engagement as a recruitment tactic.
• In a new Q&A rounding out the video interview series, Mwango Kashoki, MD, MPH, SVP and global head of regulatory strategy at Parexel, broke down the FDA's plausible mechanism framework. First-in-human studies can now serve as pivotal trials for individualized therapies, requiring sponsors to plan early FDA engagement, invest in robust non-clinical programs, qualify biomarkers, and structure adaptive trial designs from the outset to support approval.
• In a new contributed article from Pharmaceutical Executive, scaling AI in pharma requires more than algorithms. Organizations must define measurable patient-centered outcomes before deployment, build rigorous data foundations across siloed systems, and maintain human oversight at key decision points. Without cross-functional alignment on what success means, AI deployments risk optimizing computationally strong candidates with poor access or regulatory feasibility.

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