ACT Brief: Recalibrating Trial Efficiency and Access, Verana-COTA Merge to Expand RWE Scale, and FDA Rejects Hetlioz Jet Lag Indication

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part one of a new Applied Clinical Trials interview, Liz Beatty, co-founder and chief strategy officer at Inato, said sponsors are expected to maintain a strong focus on efficiency in 2026, driven by increased use of AI and technology across feasibility, site selection, and enrollment. Beatty cautioned that narrowing trials to a small group of familiar sites can unintentionally restrict patient access, and said sponsors are beginning to recalibrate by expanding partnerships with community sites, embedding research at the point of care, and using mobile and decentralized approaches to reach broader patient populations.
• Verana Health has announced a merger with COTA, bringing together two real-world data and analytics companies to expand scale and therapeutic coverage across oncology, ophthalmology, urology, and neurology. The combined organization will integrate COTA’s oncology-focused datasets with Verana’s specialty registry platform to support clinical research, regulatory submissions, and evidence generation, while strengthening FDA-facing and regulatory-grade real-world evidence capabilities.
• Vanda Pharmaceuticals said it received a decision letter from FDA’s Center for Drug Evaluation and Research stating that its supplemental NDA for Hetlioz for the treatment of jet lag disorder cannot be approved in its current form. While FDA acknowledged positive efficacy signals in the submitted trials, the agency concluded the data did not meet the standard for substantial evidence of effectiveness, citing concerns that the phase advance study designs did not adequately reflect real-world jet travel conditions.

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