ACT Brief: Trial Failures as Administrative Problems, CRO Consolidation for Global Trial Reach, and FDA Approval of First FOP Treatment

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

• In part four of her interview, Amber Hill, PhD, founder and CEO of Research Grid, explains why most trial failures are fundamentally administrative problems. Patient sourcing, site feasibility, and back-office data capture are where AI delivers the fastest and most meaningful wins, while downstream activities face harder constraints from protocol and regulatory structure.
• Curavit Clinical Research acquired Lindus Health's clinical research organization assets, giving the company a unified operational footprint across North America and Europe for decentralized, hybrid, and traditional trials. The combination addresses a market gap for sponsors needing multi-country execution without choosing between regional niche partners or legacy CROs.
• The FDA approved Regeneron's new treatment for FOP, the first therapy reducing new bone lesion formation in adults with this ultra-rare genetic disorder affecting approximately 900 patients worldwide. The Phase III trial showed reductions of 90% and 94% in new lesions at 56 weeks at two dose levels compared to placebo, addressing a condition where most patients become wheelchair-dependent by age 30.

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