ACT Brief: Trial Data Transparency, Protocol Design Drives Enrollment, FDA Shifts Approval Standards

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

• In part one of a new video interview with Marc Buyse, founder and CEO of IDDI, he discussed why confidence in clinical trial data is increasingly critical as designs grow more complex. Platform trials and Bayesian adaptive designs offer advantages but require deeper methodological scrutiny than traditional comparisons, making complete transparency and reproducibility non-negotiable for interpreting results.
• In a new column, ACT EAB member Becky Johnson, PhD, examined why recruitment and retention remain problematic despite escalating operational investment. Protocol complexity—including eligibility criteria and procedures risen over 60%—drives enrollment constraints that cannot be solved operationally alone. Data show trials with lower participant burden achieve shorter cycle times and higher completion rates, demonstrating recruitment performance is engineered through design.
• In a new video interview from Pharmaceutical Executive, Ron Lanton, senior partner at Lanton, Lanton & Sosa Law, discussed the FDA's removal of the two-trial requirement for drug approvals. While the change expedites patient access, manufacturers must consolidate resources into one comprehensive study, with enhanced post-market surveillance introducing new monitoring obligations alongside potential litigation and pricing considerations.

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