In today’s ACT Brief, we examine what will separate sponsors that scale AI beyond pilots in 2026, break down the FDA’s new draft guidance on Bayesian statistical methods in clinical trials, and explore how poor planning and trial design continue to place operational strain on research sites.
The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve efficiency, reduce timelines, and support regulatory decision-making.
See what will distinguish sponsors that scale AI into core operations from those stuck in experimentation, and why redesigning underlying processes—not just optimizing workflows—is critical to realizing long-term value.
In today’s ACT Brief, we look at how community research sites can stay competitive under efficiency pressure, why 2026 is shaping up as a turning point for platform-based clinical operations, and how AI is being positioned to better match patients to therapies.
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.
Phase IIb JASMINE data show nipocalimab met its primary endpoint in adults with systemic lupus erythematosus, marking the first positive readout for an FcRn blocker in this disease.
Assess the industry-level changes needed to ensure cancer clinical trial populations better reflect disease demographics, improve US-based enrollment, and support regulatory confidence in trial outcomes.
In today’s ACT Brief, we explore how site initiation can be leveraged to improve early trial performance through demonstrated readiness, examine how AI and decentralized infrastructure are reshaping clinical operations strategy, and review FDA’s approval of the first new pharmacologic motion sickness treatment in more than four decades.
By leveraging the Fresh Start Effect at site initiation and shifting from passive training to demonstrated readiness, sponsors and CROs can turn trial launch into a powerful multiplier for early performance, compliance, and execution quality.
Understand which barriers to cancer trial participation remain most difficult to overcome, including geography and trial centralization, and how decentralized approaches and care delivery closer to home may help close access gaps.
In today’s ACT Brief, we examine persistent barriers limiting cancer trial participation and emerging approaches to address them, outline new guidance clarifying investigator versus sponsor ownership of IRT data, and review evidence highlighting sub-Saharan Africa’s capacity to support controlled clinical trials.
Unclear boundaries between investigator-controlled and sponsor-managed data in IRT systems are creating avoidable compliance risk, particularly around investigational product inventory and quality actions.
Explore early data from the ACTS program that reveal the volume and types of patient-reported barriers to cancer care and clinical trial participation, highlighting the critical role of support services in sustaining enrollment.
In today’s ACT Brief, we examine new data from the American Cancer Society on how transportation and lodging support affect cancer trial participation, review the most-viewed Applied Clinical Trials video interviews of 2025, and break down key trial results supporting the FDA approval of narsoplimab for transplant-associated thrombotic microangiopathy.
Funding uncertainty, legal and political pressures, trade policy shifts, site collaboration strategies, and leadership perspectives were central themes across Applied Clinical Trials’ most-watched video interviews.
Learn why combining AI-enabled trial matching with transportation, lodging, and financial assistance is essential to turning trial eligibility into actual participation—and why matching alone is not enough.
