ACT Brief: AI, Equity, and Innovation Drive Clinical Research Forward

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations.

In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry.

In today’s episode, we’re spotlighting AstraZeneca’s latest advances in gastric cancer, how AI-powered patient data is improving global trial diversity, and new FDA guidance set to accelerate biosimilar development.

• We begin with a new video interview featuring Nancy Ghattas, vice president and US Oncology Commercial Franchise Head of Immuno-Oncology at AstraZeneca, who discussed the landmark Phase III MATTERHORN trial. Ghattas explained how an Imfinzi-based regimen achieved a 22% reduction in the risk of death for patients with early-stage or locally advanced gastric and gastroesophageal junction cancers. She emphasized that the findings mark the first immunotherapy regimen in this setting to demonstrate a survival advantage—representing a potential new standard of care and a major step forward in AstraZeneca’s goal of bringing curative-intent treatments to patients earlier in their cancer journey.
• Next, in the final part of our video series with Gen Li, PhD, MBA, president of Phesi, he discussed how large-scale patient data and AI analytics are helping sponsors design smarter, more inclusive trials. Drawing from a database of over 300 million patients worldwide, Li outlined how these insights can guide site selection, accelerate recruitment, and even help predict control-arm outcomes. He noted that this patient-centric, data-driven approach is key to improving representation and efficiency across global studies.
• Finally, the FDA has released new draft guidance simplifying biosimilar development requirements. The update removes the need for comparative human clinical studies, instead relying on analytical testing to demonstrate biosimilarity. The agency says the move will speed the entry of lower-cost biologic alternatives, expand access, and drive competition—without compromising safety or quality.

That’s all for today’s ACT Brief. Join us tomorrow for more insights shaping the future of clinical operations and drug development. Thanks for listening.