ACT Brief: Protocol Design as Business Strategy, Site Financial Pressures, and FDA Leadership Uncertainty

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

• In a new Q&A, Mark Freitas, managing director and life sciences practice lead at A&M, discussed how clinical trial design has evolved into strategic business decisions. Analysis of 200 FDA CRLs revealed operational rather than scientific factors drive delays, with 57% of protocols receiving substantial amendments—nearly half avoidable. Small and midsize companies face bet-the-company choices in crowded therapeutic areas where evidence strategy and competitive positioning determine success.
• In a new FAQ article, clinical research sites are navigating financial instability, payment delays, feasibility misalignment, and technology burden. Approximately 80% of sites operate with six months or less of cash on hand, making timely transparent compensation essential to survival. Leading sites are using AI to accelerate feasibility and patient matching, turning data capabilities into competitive advantage while sponsors increasingly prioritize payment experience and realistic feasibility expectations.
• President Trump is reportedly planning to dismiss FDA Commissioner Marty Makary, according to sources, adding further leadership uncertainty across federal health agencies. Makary's tenure featured controversial positions including calls for large placebo-controlled vaccine trials in lower-risk cohorts and significant shifts in drug approvals, with concerns about political fallout influencing the decision.

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