ACT Brief: Reframing Site Initiation Readiness, Operational Execution as Competitive Advantage, and a Historic Motion Sickness Approval

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

• A new ACT contributed article argues that site initiation represents a critical “fresh start” moment that sponsors and CROs can use to improve early trial execution. Rather than relying on completed training as a proxy for readiness, the article emphasizes scenario-based screening exercises, consent role play, and simulated protocol workflows to identify execution gaps before first patient visits. The approach aims to reduce early protocol deviations, uneven enrollment, and corrective retraining during the opening months of a study.
• In a new Q&A from our sister publication, Pharm Tech, Lindus Health Co-CEO Meri Beckwith reflects on how trends from 2025 are carrying into 2026, with clinical operations increasingly viewed as a strategic differentiator. Beckwith highlights broader adoption of AI to streamline workflows, improve protocol design, and accelerate timelines, alongside expanded use of decentralized trial infrastructure and real-world data. These shifts are enabling faster execution while maintaining scientific and operational rigor in an increasingly competitive development environment.
• FDA has approved Vanda Pharmaceuticals’ Nereus (tradipitant) for the prevention of vomiting induced by motion, marking the first new pharmacologic treatment for motion sickness approved in more than 40 years. Nereus is a neurokinin-1 receptor antagonist licensed from Eli Lilly and represents a notable regulatory milestone for a condition that affects both military readiness and a substantial portion of the civilian population. The approval is supported by data from three pivotal clinical studies, including two Phase III real-world provocation trials conducted in maritime settings.

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