Editorial Podcasts

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 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.

In today's ACT Brief, we explore biological and dosing considerations for basket trial designs, how human-relevant data earlier in development reduces late-stage failures, and FDA's shift toward single-trial approvals supported by real-world evidence.

In today's ACT Brief, we explore how FDA evaluates effectiveness for ultra-rare individualized therapies, the agency's enforcement push for mandatory trial result reporting, and Obsidian's merger backed by $350 million to advance next-generation TIL cell therapy.

In today's ACT Brief, we examine how protocol interpretation and source document preparation delay study startup, how the plausible mechanism framework accelerates individualized therapy timelines, and how real-time tracking technologies improve supply chain and sample integrity in decentralized trials.

In today's ACT Brief, we examine Thermo Fisher's expanded real-world data access through HealthVerity, how FHIR-based standards are finally enabling scalable eSource implementation, and FDA's second complete response letter for Replimune's oncolytic immunotherapy.

In today's ACT Brief, we explore industry perspectives on operational and methodological shifts defining 2026, how agentic AI will augment clinical trial roles over the next two years, and Roche's expanded partnership with C4 Therapeutics on next-generation antibody conjugates.

In today's ACT Brief, we examine why expanding governance layers slow digital modernization initiatives, how AI will augment clinical trial roles over the next two years, and how evolving regulatory frameworks are reshaping biopharmaceutical development timelines.

In today's ACT Brief, we explore why clinical trial diversity requires protocol redesign from the outset, the highest-impact opportunities for AI across the complete trial lifecycle, and the regulatory and operational barriers slowing companion diagnostic adoption in oncology.

In today's ACT Brief, we examine the technical and operational challenges of implementing risk-based monitoring across global trials, how AI must address social determinants of health and site burden, and the emerging role of domain-specific generative AI in clinical practice.

In today's ACT Brief, we explore the leadership priorities that enable meaningful AI gains in clinical research, how Bayesian methodologies are reshaping trial design and innovation, and proposed federal budget cuts threatening NIH research funding.

In today's ACT Brief, we examine how real-world data is being applied across oncology, ophthalmology, and other therapeutic areas to optimize trial design, how AI is reshaping clinical case intake workflows, and enrollment barriers that led Pfizer and BioNTech to halt a COVID-19 vaccine trial.

In today's ACT Brief, we explore how digital twin technology creates reliable virtual control arms from historical data, what defines an effective clinical trial tech stack in complex studies, and emerging vaccine platforms advancing toward universal influenza protection.

In today's ACT Brief, we explore how to decide which trial complexities warrant core technology platforms versus custom configurations, how measuring patient and site experiences early identifies actionable solutions, and Daiichi Sankyo's collaboration with Tempus to improve ADC patient selection through AI.

In today's ACT Brief, we explore how user-friendly technology reduces errors and site workarounds, strategic approaches to combining traditional and real-world data collection for vaccine long-term follow-up, and Merck's collaboration with Infinimmune to accelerate antibody discovery using AI.

In today's ACT Brief, we examine the three converging technology priorities reshaping trial execution in 2026, why sponsors must integrate digital and physical supply chains operationally, and Eli Lilly's multi-billion dollar AI drug discovery collaboration with Insilico.

In today's ACT Brief, we examine why eClinical platforms must prioritize user workflows over data flow, how digitizing sample tracking prevents integrity failures in transit, and the FDA's consolidated adverse event monitoring system enabling real-time safety signal detection.