ACT Brief: Clinical Development Orchestration, Career Insights in Trials, and FDA Communication Gaps

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

• In a new article, Brian O'Dwyer of IQVIA analyzed 2025 productivity data showing late-stage improvements offset by rising end-to-end timelines at 10 years. Program-level orchestration—not individual trial execution—now determines success, with transition points between phases presenting the largest remaining opportunities to reduce delays and improve coordination across teams and partners.
• In a new video interview, Sam Hinsley, statistics manager at Phastar, reflected on her career in clinical trials and what it means to do work that genuinely makes a difference for patients and the broader research ecosystem.
• In a new interview from Pharmaceutical Executive, David Crean, chief business officer at MedicNova, described FDA communication as "well-intentioned but poorly executed" due to loss of institutional knowledge following leadership transitions. Early engagement through free INDs and pre-IND meetings is increasingly critical for companies seeking regulatory clarity before late-phase surprises.

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