Federal drug officials are aiming to significantly reduce the timeline for new drug development by launching real-time clinical trials. Within the trials, clinical data will be reported in real time as the trial progresses, using cloud services and artificial intelligence.
The U.S. Food and Drug Administration launched its first real-time clinical trials in late April with AstraZeneca and Amgen.
New drugs typically require 10 to 12 years for development, according to federal officials. A substantial portion of this time, approximately 45%, is considered “dead time,” largely due to paperwork and other administrative tasks.
These real-time clinical trials are designed to import and review data in the cloud instantaneously, streamlining the current development process.
“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,” said FDA Commissioner Marty Makary in a press release.
“The idea is all the data is going to stream into a secure digital platform, and the regulators and the researchers will have constant access to it,” said Dr. Nicki Byrne, Medical Director of concierge, longevity-focused medical practice Optispan.
Dr. Byrne says artificial intelligence is already being used across the healthcare industry. She uses it to help her patients at Optispan.
“We’re doing genetics, we’re doing wearables so we’re getting sleep data, and we’re doing movement trackers, and we’re watching glucose monitors,” she said. “So we’re using AI already to aggregate that data, to help me find the trends, and it really augments my clinical decision making.”
She says cutting down the time in trials, if possible, could save lives. Though she cautions the use of artificial intelligence isn’t risk-free.
“I think the really big risk is the over-reliance on AI,” she said. “So, having someone not using their critical thinking and just seeing, ‘This trend might be due to this,’ instead of actually really evaluating what that trend is from.”
Her concerns are echoed by Kimberly Chew, a litigation and regulatory attorney focused on life sciences at Husch Blackwell.
“This is genuinely promising, and we support FDA modernization,” Chew said. “We don’t want it to be at the expense of undermining the trustworthiness of the regulatory system.”
One of Chew’s concerns is about miscoded data, or data that has accidental errors. If these errors are uploaded in realtime before they’re caught, they could have major implications for companies behind the trials.
“Publicly traded biotech or big pharma companies, their stock could drop before the facts have been verified,” she said.
She also warns smaller companies might not have the operational bandwidth or financial ability to execute these trials in a way that larger companies could.
A third concern involves risk of exposure for confidential information or information that involves intellectual property.
“These were existing protections that were developed for traditional submissions and not for continuous data flow,” she said. “So there is just a concern to point out that that’s a potential risk.”
Chew hopes guardrails are explored during the FDA’s public comment period. The agency is currently collecting public feedback as it looks to expand the real-time clinical trials into a larger, broader pilot program.