ACT Brief: Diversity Built Into Trial Design, AI Impact Across Trial Lifecycle, and Companion Diagnostics Adoption

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 article series, Olga Elizarova, DDS, MPH, MBA, senior consultant behavioral science at S3 Connected Health, examined why diversity in clinical trials cannot be achieved through last-minute recruitment efforts. Meaningful representation requires designing protocols, sites, and enrollment strategies around the real barriers and needs of underrepresented communities from the outset, including accessible locations, flexible schedules, and investigators who reflect the communities being recruited.
• In part four of his video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, mapped the highest-impact opportunities for AI across the trial lifecycle—from smarter protocol design and enrollment matching to data collection, cycle time compression, and the emerging potential of synthetic data in rare disease applications.
• In a new contributed article from Pharmaceutical Executive, companion diagnostics face significant adoption barriers including evidence generation timelines of five to ten years, transition from research-grade to clinical-grade assays, workflow integration challenges, and reimbursement delays. Pharma-diagnostic co-development with parallel validation and approval can accelerate access, while NGS-based platforms delivering results in 24 hours are enabling faster treatment decisions and stronger trial enrollment.

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