HHS launches ‘Operation Trialblazer’ aimed at speeding early trials

The U.S. Department of Health and Human Services has launched Operation TrialBlazer, a coordinated roadmap aimed at modernizing the country's clinical research infrastructure and reducing delays in early-phase drug development.

The initiative involves the FDA, NIH, ARPA-H, and the Office of the National Coordinator for Health Information Technology (ONC), and addresses six areas: regulatory requirements, sponsor transparency, operational efficiency, trial design rigor, data utilization, and patient and clinician access to trials.

The FDA's portion of the roadmap focuses on two near-term priorities. The first is accelerating the time to first-in-human trials by clarifying CMC and pharmacology/toxicology requirements for IND applications, with the agency estimating that a risk-based, phase-appropriate approach could save sponsors six to twelve months compared to current submissions. The second priority is reducing administrative burden in later-stage development, including potential rulemaking to require a single IRB (sIRB) model for multi-site cooperative studies — a reform that would align FDA regulations with existing NIH and Common Rule policy.

A new expedited-IND acceleration pilot will establish a network of Qualified Research Institutions (QRIs) — academic medical centers, healthcare networks, and contract research organizations — to conduct rolling pre-submission reviews of IND components. FDA reviewers would assess submissions on a rolling basis as components are completed, rather than waiting for a full package. The agency would retain full regulatory authority over all IND decisions.

The 22-page document frames the new initiatives as a direct response to the U.S. losing ground in the global race for early-stage clinical research. China is singled out for its investigator-initiated trial model, which allows drugs to move into human testing as soon as a researcher has interest and funding, and for regulatory reforms that have made its discovery-to-IND cycles 50-70% faster than the rest of the world. Australia draws mention for its Clinical Trial Notification System, which can get trials underway in fewer than 70 days from final protocol submission. "Too often, the U.S. pathway can be measured in years, while other countries' pathways are measured in months," the document states.

Read our recent cover story about China’s rise in early cell and gene therapy trials.