FDA Takes Major Step to Speed Clinical Trials

At long last, the Food & Drug Administration is taking steps to speed the drug approval process.

What most people don't realize, FDA Commissioner Marty Makary said, is that nothing happens during about 45% of the time a clinical trial is taking place.

That's because testing of new drugs typically takes place over three phases, and each phase is run as a separate study. So, there is generally a pause which data from that phase is compiled manually, forwarded to FDA and reviewed by the agency before the next phase begins.

Real-time trials allow the FDA to view key insights in real time, this hiatus could be eliminated or reduced to a minimum, enabling “continuous” trials.

“For 60 years, we've been conducting clinical trials in the same way, where key data signals can take years to reach the FDA. The lag time can delay regulatory decisions unnecessarily and slow down the drug development timeline,” Makary said.

Now, thanks to cloud computing, the integration of electronic medical records and similar technical advances into the clinical trial process, "FDA scientists will be able to view safety signals and endpoints in real time as a trial progresses. This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development," Makary said.  

Two real time clinical trials are underway to prove the concept. The FDA doesn't conduct any clinical trials itself. Rather, drug companies team with academic medical centers to conduct the trials. They compile data manually, send it to FDA for review. Each drug application is a three-step process, with review occurring at the end of each of three phases.

The current proof-of-concept real-time clinical trials involve two drugs.

• AstraZeneca is conducting a Phase 2 multi-site trial, TRAVERSE, in patients with treatment-naïve mantle cell lymphoma, with participation from The University of Texas MD Anderson Cancer Center and University of Pennsylvania.
• Amgen is conducting a Phase 1b trial, STREAM-SCLC, in patients with limited-stage small cell lung carcinoma and final site selection is in process. 

For each trial, the FDA met with the drug company to establish criteria for reporting signals in real time. The agency has since received and validated signals for AstraZeneca’s trial through Paradigm Health, thereby establishing the feasibility of the technical framework required for real-time signal sharing.

“Real-time trials have been talked about for years. We demonstrated that it is not only possible, but also potentially transformative for the clinical trials ecosystem,” said Chief AI Officer Jeremy Walsh. “We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment.”