HHS Launches Operation TrialBlazer to Streamline US Clinical Trials
In-house counsel for small and mid-sized biopharmaceutical companies must monitor these reforms to help shape streamlined pathways that reduce barriers to US-based early-phase clinical research.
On June 22, 2026, HHS launched Operation TrialBlazer, a departmentwide initiative to reverse the years-long migration of early clinical trials to foreign jurisdictions including China and Australia, where Phase 1 trial start timelines are 40% shorter on average than in the US. As part of the push, FDA is piloting a risk-based expedited IND pathway for Phase 1 trials that cuts redundant administrative requirements, and has formally asked Congress to codify a permanent streamlined option. Biopharma in-house counsel should track public rulemaking, submit comments during open comment periods, and engage with HHS agencies to provide input on pathway implementation to reduce operational barriers to US-based early-stage research.