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In today's ACT Brief, we examine AI replacing unreliable feasibility estimates with precise patient matching, three tensions reshaping clinical operations culture, and FDA's first oral post-exposure COVID-19 prevention therapy.

In this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, explains how AI is replacing unreliable feasibility estimates with precise, real-time patient matching—and what that means for reducing non-enrolling sites and screen failure rates.

Optimization challenges spurring cultural, strategic, and organizational change.

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.

As the FDA formally recognizes real-world evidence as eligible confirmatory evidence for drug approval, sponsors face a growing imperative to build the data infrastructure, organizational alignment, and analytical capabilities needed to use RWE effectively across the development lifecycle.

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

In this video interview, Abraham Gutman, founder and CEO of AG Mednet, shares his key takeaways from SCOPE X, including a pointed caution against the idea that agentic AI can run clinical trials autonomously and why process architecture is the real entry point for AI to deliver on its promise.

In today's ACT Brief, we examine how AI handles rote tasks to free human experts for critical decisions, what authentic community engagement requires beyond recruitment, and recent lupus treatment advances shifting standard of care.

In this Q&A, Del Smith, PhD, CEO and co-founder of Acclinate, discusses how structural and relational barriers continue to limit participation from underrepresented communities in clinical trials—and what it takes to build the kind of trust that translates into lasting research impact.

In today's ACT Brief, we examine why decades of data capture progress haven't solved trial execution, study coordinator performance on document reviews, and FDA advisors voting on updated COVID-19 vaccine composition.

Study coordinators identify only about 45% of critical and major problems during document reviews, with substantial performance variability across experience levels, but focused training can improve detection rates from 45% to approximately 68%.

In this video interview, Abraham Gutman, founder and CEO of AG Mednet, explains why decades of progress in data capture have not solved the execution problem in clinical trials, and what an operational architecture for AI actually looks like in practice.

In today's ACT Brief, we examine why paper-based outcome assessments persist despite clear data-quality disadvantages, why early phase statistical decisions shape entire development pathways, and the structural changes needed for representative enrollment.