Editorial Podcasts

In today's ACT Brief, we examine building governance into every trial stage, how agentic AI is compressing RTSM startup timelines, and why state medical access programs could strengthen rather than undermine clinical trials.

In today's ACT Brief, we examine how FDA continuous data review exposes trial infrastructure gaps, vaccine trial standardization amid regulatory uncertainty, and a major collaboration on a BTK degrader for blood cancers.

In today's ACT Brief, we examine how cross-asset site partnerships drive data sharing, standardized eCOA templates accelerating vaccine trial startup, and real-world data revealing ovarian cancer disparities.

In today's ACT Brief, we examine why site technology fragmentation blocks AI adoption, how agentic orchestrators and lakehouse architectures enable real-time clinical data harmonization, and evidence-based strategies to reduce obesity trial discontinuation.

In today's ACT Brief, we examine AI-enabled site performance in a Sanofi COPD study, why statisticians raising early phase standards matters to the entire development pathway, and a new partnership on RNA exon editing for monogenic kidney disease.

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 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.

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 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 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 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.

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 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 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.

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.

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.

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.

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.

In today's ACT Brief, we examine CRIO and Medidata's partnership on seamless clinical trial data flow, Tufts CSDD findings on direct-to-patient site enrollment and diversity outcomes, and TransCelerate's work with FDA on selective safety data collection for pragmatic trials.

In today's ACT Brief, we examine governance inertia when AI accelerates protocol development, why payment experience is becoming a competitive differentiator for sites, and FDA approval of Caplyta for relapse prevention in schizophrenia.

In today’s ACT Brief, we highlight where AI is delivering real gains in protocol development, how geopolitical disruption is redefining supply chain resilience, and the growing global impact of real-world evidence in drug development.

In today's ACT Brief, we examine Veristat's acquisition of Certara's regulatory business, why reimbursement probability should inform development planning earlier, and how site selection misalignment drives downstream trial performance issues.

In today's ACT Brief, we explore organizational factors behind CRL decisions, methodological concerns with pooling amyloid antibody trial data, and how compounding addresses care gaps when commercial options fall short.

In today's ACT Brief, we explore practical community engagement strategies that drive representative enrollment, how sponsors should structure development plans around the plausible mechanism framework, and the organizational prerequisites for scaling AI effectively in drug development.

In today's ACT Brief, we explore practical steps sponsors can take to prepare for the plausible mechanism framework, how behavioral science addresses root causes of recruitment and diversity challenges, and FDA acceleration of psychedelic therapy reviews through executive order.

In today's ACT Brief, we explore how disease heterogeneity confounds natural history controls, the execution translation gap converting identified problems into action, and policy recommendations for strengthening FDA's accelerated approval pathway.