The United States’ International Competition for Clinical Trials

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: What countries is the US competing with for clinical trial control
Dr. Richard Graham: The way I think about it, based on what I've been seeing in the work I've been doing, is that for Phase 1 studies, companies are primarily going to Australia for the reasons we just discussed. For later-stage trials, starting as early as Phase 1b in patients but certainly through Phase 2 and sometimes Phase 3, there's a significant push to do that work in China. So it's actually both countries, both regions, but I think about it by phase or stage.

Now, if we shift gears and think about those later-stage trials, which TrialBlazer doesn't directly contemplate the way it does the expedited IND review process, China has done a remarkable job of getting trials up and running fast, far faster than they used to, and completing them faster than we do in the United States. There are multiple reasons for that. One is the large pool of treatment-naive patients available for enrollment. The other is that China ran a top-down, state-coordinated program that essentially said: sites, sponsors, and CROs, work together to make this happen. I'm not suggesting we replicate that model in the United States. I am fairly certain that we are missing the mark with TrialBlazer and the other initiatives we've discussed, because we have so many stakeholders involved in running a clinical trial in the US, and they are not all working toward the same goal.

Think about it as a diagram with the trial at the center and spokes radiating outward: patients, sponsors, sites, CROs, investors, payers, regulators. How can we fix one small piece that one stakeholder cares about and expect everything to suddenly move fast enough to outpace China? I'm not offering a solution here, but I am highlighting a problem that is solvable. In my view, we are not thinking holistically about what the underlying issues actually are.