ACT Brief: Endpoint Selection and Patient Engagement, Execution Infrastructure Before AI, and Real-World Data Quality Gaps

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

• In part three of her interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, describes how shifting patient engagement from protocol review to endpoint selection transforms both the quality of trial data and the experience of participation. When patients shape which outcomes matter, trials measure what actually matters to the people they serve and generate more clinically meaningful results.
• In a new FAQ, we addressed why clinical trial infrastructure has to be built before AI can deliver, examining the execution gaps in decision workflows, data collection design, and lab connectivity that remain fragmented. Trials have perfected data capture but neglected the workflows underneath that determine whether that data is trustworthy and actionable, leaving AI deployed on top of an incomplete foundation.
• In a piece from Pharmacy Times, Carole Berini, PhD, and Saamir Pasha, MPH, of Ontada discussed a model designed to estimate missing baseline ECOG performance status in advanced prostate cancer. ECOG performance status is critical for oncology real-world evidence research but is frequently unavailable at specific time points, limiting sample sizes and introducing selection bias in patient populations.

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