Where the True Bottlenecks Exist at FDA 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: Where do the true bottlenecks exist at FDA when it comes to clinical trials?
Dr. Richard Graham: I don't want to sound negative, because I think directionally, people and organizations are trying to do the right thing. But here's what bothers me, and let's use TrialBlazer as the example.

We just talked about expediting the IND review process. That falls into what I think of as the startup phase, or everything that happens before a study is actually executed. If you break a clinical trial into three phases: startup, execution, and then analyzing and reporting data. The execution phase is where I see the vast majority of bottlenecks, and it's where almost no meaningful work is being done to address them.

Why is that? Probably because the execution phase is the one that the people who control clinical trials at the top have the least visibility into and the least direct control over. The entities with the most control in that phase are clinical trial sites and CROs — and that's exactly where the inefficiencies compound. Enrollment takes far too long because of systemic inefficiencies at the site level.

Here's a concrete example. The TrialBlazer document that HHS released includes a section I genuinely appreciate, which argues that in order for the United States to reclaim clinical trials that are now being run overseas, we must be innovative and on the leading edge of technology. I agree completely. But at TruTechnologies, every time we initiate a new study for a client, we receive a blanket letter from one of the major cancer centers in the United States, a center everyone in the industry would recognize, that says, in effect: we are not willing to embrace clinical trial technologies in our lab, and we expect you to send us paper case report forms. That is not innovation. But that is the reality at the site level.