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

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.