How Realistic Project TrialBlazer’s Stated Goals Are

FDA’s latest initiative to improve the drug approval process is Project Trialblazer. The pilot program is designed to accelerate early-stage clinical trial.

This effort comes as the global clinical trial space is becoming more competitive, and many companies are moving their trials to other countries, such as China and Australia. The current administration hopes to solve this issue by simplifying the entire trial process.

According to the initial announcement, FDA hopes that this initiative will reduce clinical trials by six-to-12 months, which would hopefully bring more trials back to the United States.

Pharmaceutical Executive spoke with Dr. Richard Graham, chairman and co-founder of TruTechnologies about FDA’s new program and how he expects it to impact clinical trials. He also discusses why trials are actually leaving the United States and where he sees the true bottlenecks in FDA’s approval process.

Pharmaceutical Executive: How realistic are the goals set by Project Trialblazer?
Dr. Richard Graham: Operation TrialBlazer incorporates multiple elements, largely regulatory, operating through HHS. The first component you're mentioning could cut several months from development timelines; six to twelve months is the figure that's been cited, and that was largely framed around reducing the time required for IND review.

There is a relatively lengthy process from the time a company begins working on an IND to the time that IND is approved in the US and patients can be dosed. As we've discussed, that's quite different from Australia, which has invested significantly in building the infrastructure to support its CTN process, which is effectively the equivalent of no IND at all.

So TrialBlazer is directionally correct in the sense that we should be removing regulatory friction and moving faster. But you're competing with a system that requires no IND. It's hard for me to reconcile how this is going to produce a meaningful improvement when many of the companies I work with today are already defaulting to Australia for their Phase 1 studies. Once the toothpaste is out of the tube, it's hard to put back in.

Directionally, I think this is the right move, but I'm struggling to understand how it will actually shift company behavior back toward filing INDs in the United States, when the path they're already on is filing in Australia. And that's before you factor in the significant R&D tax credits that come with conducting studies there.