News

Examining how shifting leadership patterns in breast cancer research signal growing international participation—and the continued need for broader equity in global trials.

As decentralized and hybrid trial models expand, eConsent is emerging as a critical tool for improving participant understanding, reducing site burden, and strengthening data integrity through digital automation, accessibility, and regulatory compliance.

In today’s ACT Brief, we revisit key insights from SCOPE Summit 2025 on AI and pragmatic trials, examine Genentech’s Phase III vamikibart data in uveitic macular edema, and highlight MJH Life Sciences’ acquisition of BPD Healthcare—expanding the bridge from discovery to delivery.

At AAO 2025, Genentech reported that vamikibart, a first-in-class IL-6–targeted antibody, led to rapid improvements in visual acuity and macular thickness in patients with uveitic macular edema, supporting its potential as a non-steroid treatment option.

Revisit top insights from SCOPE Summit 2025, where industry leaders explored how artificial intelligence is reshaping trial risk management and how pragmatic study designs are bridging the gap between clinical research and real-world care.

Today’s ACT Brief highlights how artificial intelligence is transforming trial data management, why biotechs are embracing parallel execution to accelerate development, and new Phase III results showing Imfinzi’s potential to redefine early-stage bladder cancer treatment.

How a unified approach to clinical data management, powered by artificial intelligence and advanced analytics, can elevate clinical trial monitoring and redefine how teams assess, act on and learn from data.

At ESMO 2025, AstraZeneca reported that Imfinzi plus BCG therapy reduced the risk of recurrence or death by 32% in patients with high-risk non-muscle-invasive bladder cancer, marking a potential new standard in early-stage disease.

Learn how early regulatory engagement, validated digital systems, and robust protocol design enable biotechs to run parallel studies without compromising compliance or data integrity.

In this week’s Applied Clinical Trials Brief, we highlight key findings from the 2025 State of the Industry Survey, explore how AI is transforming trial efficiency and patient engagement, and examine strategies to safeguard global research operations against rising tariff risks.

See how integrated teams, data visualization, and full-service coordination between clinical, regulatory, and commercial functions can accelerate decision-making and development speed.

New results from the Phase III MATTERHORN trial show AstraZeneca’s Imfinzi combination reduced the risk of death by 22% versus chemotherapy alone, marking a major advance for patients with resectable gastric and gastroesophageal junction cancers.

See how early patient inclusion, integrated regulatory planning, and seamless CRO partnerships can help biotechs accelerate progression from Phase I to Phase II.

Advancing toward more meaningful use of PRO data by making it systematic, transparent, and built into trial design.

Praxis Precision Medicines’ Essential3 program met all primary and key secondary endpoints, with ulixacaltamide showing significant improvements in tremor control and daily functioning in patients with essential tremor.

As pharma wrestles with whether to trust fully autonomous AI, semi-autonomous agents are emerging as a safer middle ground that reduces manual work, eliminates white space in clinical development, and accelerates trial timelines without compromising patient safety.

The quest to turn patient retention from a chronic challenge into a competitive strength—and one that benefits all stakeholders.

Understand how intelligent study design, focused data collection, and faster analytics can help clinical teams deliver meaningful results that sustain investor momentum.

Eli Lilly’s oral GLP-1 therapy, orforglipron, met all primary and key secondary endpoints in the Phase III ACHIEVE-2 and ACHIEVE-5 studies, showing significant A1C reduction, weight loss, and cardiovascular benefits compared to both dapagliflozin and placebo.

With global supply chains inherently vulnerable to trade policy shifts, the consequences for clinical research can be significant without proactive planning. The eight core elements of a tariff contingency plan are outlined.

Gain insight into why early toxicology readiness and strong scientific collaboration with CRO partners are critical to accelerating trial startup and regulatory approval.

How a strategic approach to the pre-investigational and investigational new drug application process can be used as a business and clinical catalyst.

Uncover how improving data accuracy and leveraging synthetic control arms can optimize trial efficiency, reduce costs, and generate stronger real-world insights.

Sustainability should be central to clinical trial design and considerate of how digital tools such as electronic clinical outcomes assessments can help achieve this.

Although DEI remains a core tenet in pharma, strategies and goals have been reframed to align with the evolving political climate.

To maximize the impact of signal detection, KRI frameworks should follow a few guiding principles.

Examine strategies for validating, monitoring, and safely deploying configurable AI agents to ensure compliance and performance in clinical trials.

Capturing insights from clinical research professionals on the key trends and challenges shaping drug development today, from those in clinical trial operations and site relationships, to technology and AI, and the evolving regulatory and policy terrain.