Andy Studna, Senior Editor

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.

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.

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 this video interview, Abraham Gutman, founder and CEO of AG Mednet, describes how AI can take on rote reasoning tasks like PHI redaction and document QA, and why offloading that work is what gives human experts the clarity to focus on genuine decision making.

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.

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.

Despite political headwinds, life sciences leaders are holding their ground on DEI, but translating organizational commitment into representative enrollment requires structural changes to protocol design, site selection, and community engagement that most of the industry has yet to fully make.

In this video interview, Sam Hinsley, statistics manager at Phastar, explains why early phase decisions are the foundation of the entire development pathway and what is at stake statistically when those decisions are made on limited data.

In today's ACT Brief, we examine how Merck embeds diversity into trial execution from design through community engagement, a new statistician special interest group for early phase research, and FDA's first approval for chronic hepatitis delta virus.

In this video interview, Sam Hinsley, statistics manager at Phastar, introduces the Early Phase ESIG, a new special interest group bringing together statisticians from across academia and industry to share knowledge and raise standards in early phase research.

In today's ACT Brief, we examine what succeeding under compressed FDA review timelines requires, why statistician collaboration is essential as trial complexity grows, and GLP-1s reshaping pharma portfolio strategy.

The CNPV program has compressed drug review timelines to as little as one to two months for qualifying sponsors, but succeeding under that pressure requires a fundamental rethink of how development teams plan, communicate, and execute.

In this video interview, Sam Hinsley, statistics manager at Phastar, makes the case that as trial designs grow more complex, collaboration between statisticians and clinical experts is not just helpful but necessary to get meaningful answers.

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.

In this video interview, Sam Hinsley, statistics manager at Phastar, explains how statisticians can ensure patient data is used responsibly and innovatively across every phase of development, from rare disease to personalized medicine to AI.

In today's ACT Brief, we examine how program-level orchestration is becoming critical to R&D success, reflections on meaningful work in clinical trials, and industry concerns about FDA communication and institutional knowledge loss.

In this video interview, Sam Hinsley, statistics manager at Phastar, reflects on why she chose a career in clinical trials and what it means to do work that she believes makes a genuine difference.

In today's ACT Brief, we examine safety signal prioritization in RBQM, widening performance gaps between early AI adopters and the broader industry, and data quality concerns in FDA's real-time clinical data review initiative.

A survey of 200 senior life sciences decision makers finds a widening performance gap between organizations that have scaled AI and those still navigating the barriers to enterprise adoption.

In today's ACT Brief, we examine how improving representation changes trial design at Merck, revenue recognition challenges in CRO contracts, and FDA's pilot program for real-time clinical data review.

In today's ACT Brief, we explore how Let's Talk Trials addresses clinical trial awareness gaps, why participant readiness matters more than digital tools alone, and FDA's increasing scrutiny of AI use in regulatory and quality processes.

In today's ACT Brief, we explore how diversity is embedded across trial planning at Merck, integration of patient-reported and wearable-derived outcome measures, and AI applications in reducing clinical trial failure rates.

The deal combines patient-reported outcomes with wearable-derived sensor data under a single provider, aiming to simplify multimodal evidence generation for clinical trial sponsors.

In today's ACT Brief, we examine leadership instability and regulatory uncertainty during Makary's FDA tenure, how lived experience shapes pediatric trial design and performance, and Eli Lilly's weight loss maintenance data for obesity therapies.

FDA Commissioner Marty Makary’s departure caps a turbulent tenure marked by leadership instability, industry pushback, and a series of regulatory controversies that complicated drug development for sponsors and CROs.