ACT Brief: The Evolving CRA Role, New Immunotherapy Standard in Gastric Cancer, and Priority Review for Higher-Dose Wegovy

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.

A new feature article explores how the role of the clinical research associate is undergoing a significant shift as trials become more decentralized, data-rich, and technology-enabled. CRAs are transitioning away from exhaustive source data verification and toward strategic site partnership—requiring proficiency in digital platforms, centralized monitoring tools, and multi-system data workflows. The piece underscores how modern oversight increasingly depends on hybrid monitoring models, integrated data review, and the CRA’s ability to interpret signals, collaborate across functions, and support sites in navigating fragmented technology environments. As AI-driven analytics and centralized monitoring continue to mature, CRAs are expected to play an even more central role in risk detection, site relationships, and operational decision-making.

The FDA has approved AstraZeneca’s Imfinzi in combination with perioperative FLOT chemotherapy, marking the first immunotherapy regimen for resectable early and locally advanced gastric and gastroesophageal junction cancers. The approval, based on Phase III MATTERHORN results demonstrating a 22% reduction in the risk of death versus chemotherapy alone, establishes a new standard of care in this setting. With both neoadjuvant and adjuvant components included in the regimen, the decision signals a shift toward immunotherapy earlier in the treatment pathway and is expected to influence trial design, site readiness, and perioperative oncology research strategies moving forward.

Novo Nordisk has submitted its higher-dose 7.2 mg Wegovy injectable for FDA review, leveraging the agency’s new Commissioner’s National Priority Review Voucher program to shorten the process to as little as one to two months. The submission is supported by Phase III STEP UP data showing enhanced weight-loss efficacy compared to both placebo and the existing 2.4 mg dose. If cleared, the new strength would expand therapeutic options within the semaglutide class and further accelerate clinical activity in obesity drug development, especially as more products enter expedited pathways under FDA’s pilot program.

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