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.
Clinical Trials Day is an international celebration of everyone who makes medical discoveries possible. It is also an opportunity to shine a light on the innovations helping to keep research rising.
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.
Clinical development productivity improved in 2025, but gains remain fragile as end-to-end timelines lengthened again, signaling that future success depends less on individual trial execution and more on program-level orchestration, site engagement, and adaptive operating models.
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.
Safety monitoring generates substantial signal volume across risk-based quality management tools, but only 30% to 36% of signals correspond to confirmed issues, suggesting the need for better prioritization, signal consolidation, and alignment between detection and proportional action.
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.
Managing financial integrity in a complex, milestone-driven operating model.
In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen describes how improving representation has changed trial design and site selection at Merck, where the hardest barriers remain, and what the industry will need to sustain meaningful progress over the next five years.
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.
Participant adherence depends on readiness—a combination of knowledge, calibrated confidence, and real-world mastery—not simply on digital tools, reminders, or education, which are forms of exposure rather than preparation for sustained performance.
In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen explains how Let's Talk Trials was designed to address gaps in clinical trial awareness and access, what differentiates it from earlier efforts, and how trust sits at the center of the initiative's approach.
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.
In this conversation between Rebecca Johnson, PhD, ACT EAB member and clinical research recruitment and inclusion executive and strategist; and Adrelia Allen, executive director of clinical trial patient diversity at Merck, Allen discusses how diversity in clinical trials has become embedded in how Merck designs and executes its studies, and what accountability looks like internally across trial planning and community engagement.
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.
Pediatric trial participation shapes children's and caregivers' long-term psychological outcomes, yet protocol design often overlooks experience as a variable affecting recruitment, retention, and data integrity—a gap increasingly recognized by regulators and quality standards
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.
In today's ACT Brief, we examine cost models for imaging infrastructure in clinical trials, how community relationships improve protocol design and site placement, and FDA leadership changes.
As imaging-heavy clinical trials grow more complex and globally distributed, sponsors are increasingly re-evaluating traditional infrastructure models, with cloud-native platforms showing potential to reduce operational burden, accelerate site activation, improve imaging quality oversight, and lower total trial costs.
In this video interview, Del Smith, PhD, CEO and co-founder of Acclinate, explains how deep community relationships generate insights that improve protocol design, endpoint selection, and site placement, while building an on-ramp that compounds in value across future studies.
In today's ACT Brief, we examine how protocol design decisions have become strategic business choices with outsized consequences for smaller companies, what clinical research sites need to compete and deliver, and leadership changes at the FDA.
From payment delays and feasibility misalignment to technology burden and AI adoption, clinical research sites are navigating a convergence of pressures that increasingly determine who sponsors work with and how well trials perform.
