
Metrics & Benchmarks
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The Challenges of Buying Blind: Why Providing the Clinical Outcome Assessment Measure Prior License Execution Would Significantly Benefit Clinical Trial Set-Up

Moving Beyond Historical Site Data to Real-Time Patient Insight

ACT Brief: Trial Competition Slows AI Gains, Rethinking Patient-Level Safety Decisions, and What Separates Real AI Platforms in Clinical Trials

Reasoning About Individual Drug Causality in a Multifactorial World

Why Trial Competition Is Undermining AI-Driven Gains

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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.






















