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Extending Trial Registries for an AI-Driven Era of Patient Discovery

ACT Brief: Moving Beyond AI Pilots, FDA Advances Bayesian Trials, and Sites Strained by Trial Design

FDA Issues Draft Guidance to Advance Bayesian Methods in Clinical Trials

Breaking Out of AI Pilot Mode in Clinical Development

ACT Brief: Community Sites Prove Readiness, Platformization Reshapes Clinical Ops, and AI Targets Precision Care at JPM

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The clinical trial ecosystem is entering a phase of consolidation and reinvention driven by the collapse of boundaries between functions, data, and even companies themselves.

In today’s ACT Brief, we examine how community research sites can stay competitive under rising efficiency pressures, why clinical outcome assessment licensing remains a drag on trial start-up, and what’s holding back AI-driven pharmacovigilance at scale.

Examine the strategies community research sites can use to secure trial opportunities, from adopting AI-enabled workflows to proving verified access to underrepresented patient populations.

Persistent delays and inefficiencies in COA licensing and translation stem from limited pre-license access and fragmented processes, making a strong case for providing outcome assessment measures earlier to reduce risk and accelerate trial start-up.

Learn how real-time patient eligibility data is reshaping trial planning and site selection, allowing sponsors to design more inclusive studies based on current patient reality rather than past performance.

In today’s ACT Brief, we look at how growing trial competition is undermining AI-driven efficiency gains, why pharmacovigilance is shifting toward patient-level causal reasoning, and what AI life sciences companies must demonstrate to stand out in a crowded market.

Pharmacovigilance has advanced in detecting population-level safety signals, but a critical gap remains in translating those insights into transparent, defensible patient-level decisions.

Unpack how rising competition for the same high-profile sites is slowing startup and enrollment—and what sponsors must change in their site strategies to ensure AI-enabled efficiencies translate into real-world impact.

In today’s ACT Brief, we hear how sponsors may redefine efficiency to protect patient access in 2026, review Verana Health’s merger with COTA to expand real-world evidence capabilities, and examine FDA’s latest decision on Vanda’s Hetlioz for jet lag disorder.

Verana Health’s merger with COTA expands real-world data and analytics capabilities across oncology and specialty care, strengthening research-ready evidence generation for biopharma, regulatory decision-making, and clinical development.

Explore how sponsors can recalibrate efficiency efforts to avoid overconcentrating trials at familiar sites and instead expand access through community partnerships, point-of-care research, and intentional outreach models.

In today’s ACT Brief, we examine the growing challenges of sourcing comparator drugs across the EU, highlight a new AI-driven oncology collaboration between BostonGene and AstraZeneca, and explore why AI life sciences companies are being pushed to prove real operational value beyond hype.

BostonGene has entered a new collaboration with AstraZeneca to apply its foundation AI model to oncology drug development, aiming to improve early trial decision-making around safety, efficacy, and biomarker strategy while accelerating clinical timelines.

Comparator drug sourcing in the EU is shaped by a defined set of availability, regulatory, competitive, and logistical pressures, alongside practical strategies to reduce risk and protect trial timelines.

In today’s ACT Brief, we examine why representative enrollment remains a barrier in US cancer trials, review Johnson & Johnson’s positive Phase IIb results for nipocalimab in systemic lupus erythematosus, and break down a new multibillion-dollar research and licensing agreement between Nimbus Therapeutics and Eli Lilly targeting oral obesity treatments.






















