ACT Brief: Operation TrialBlazer Launched, Protocol Complexity Rising, and Data Infrastructure for AI

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

• HHS launched Operation TrialBlazer, a coordinated FDA and NIH effort to reduce US trial friction and counter China's growing clinical research share. The initiative includes an Expedited IND pilot with rolling institutional submissions, a Phase I Contact Center, updated CMC guidance for early-stage trials, and single-trial approval flexibility for late-stage programs.
• New research published on ACT examined protocol complexity across 190,000 trials from 2004–2025, finding endpoints doubled from median 3 to 7, driven almost entirely by secondary endpoints. Failure rates rose modestly from 10.2% to 13.2%, with Phase II consistently the highest-failure phase and oncology now representing 34% of clinical trial activity.
• In a Pharmaceutical Technology article, Partha Anbil and Vineet Kumar evaluated three clinical data management architectures—warehouses, lakes, and lakehouses—using FAIR principles plus the 5 V's framework to guide selection for bias-controlled, interoperable AI development.

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