News|Podcasts|May 20, 2026

ACT Brief: Safety Monitoring Alignment, AI Performance Gap Emerging, and Real-Time Data Quality Challenges

In today's ACT Brief, we examine safety signal prioritization in RBQM, widening performance gaps between early AI adopters and the broader industry, and data quality concerns in FDA's real-time clinical data review initiative.

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

In a new RBQM column, ACT board member Sylviane de Viron and Frederic Blais analyzed safety reporting across 2,000 clinical studies. Only 16% of identified safety risks are rated high, yet studies generate approximately 10 signals leading to 8 actions per study—but only 30-36% of signals correspond to confirmed issues. Better prioritization and signal consolidation across KRIs, SDM, and QTLs can move sponsors from reactive to proactive safety management.
Medidata's 2026 State of AI in Clinical Trials report finds early adopters with 18+ months of experience reporting 73% reduction in trial timelines and 68% reduction in protocol deviations. Meanwhile, 79.5% of broader industry cites integration complexity as a barrier. Investment appetite remains strong with 92% planning increased spending and expectations for 2-3x ROI within 12-24 months.
In the second part of an interview from Pharmaceutical Executive, Dr. Richard Graham cautioned that FDA's real-time data review initiative risks drawing misleading conclusions if upstream data capture at sites is imprecise. Graham emphasized the importance of clarifying what "real-time" means and ensuring data accuracy before aggregation, rather than analyzing smaller sample sizes mid-trial when quality control is incomplete.

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

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

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