The regulatory gears in the U.S. are increasingly creaking under the weight of new, complex drug technologies and intensifying overseas clinical trials competition from countries like China and Australia.
Now, the Department of Health and Human Services is making moves to speed early drug research under a new plan dubbed Operation Trialblazer. The blueprint, which involves initiatives at multiple federal agencies, including the FDA and the National Institutes of Health, focuses on modernizing regulations and processes, improving patient access and participation, and enhancing the use of data and technology to streamline the regulatory process.
It’s the latest in a series of actions aimed at supporting drug research. But whether the new reforms will hit the target is an open question.
“It's a step in the correct direction, but the reality is regulatory speed does not necessarily equate to scientific success,” said Dr. Francisco Beca, chief medical officer at QuantHealth, an AI clinical trial company.
What also matters, he noted, is ensuring strong trial design, an area where sponsors often fall short.
“If you speed up a poorly designed trial or speed up review, it doesn't mean that you're getting more conversions into actual drugs that will reach American patients with the quality the FDA has gotten used to,” Beca said.
What HHS is changing
The Chinese government has laid critical groundwork in recent years that allows drugs to move from early research to investigational new drug application 50% to 70% faster than in other countries, prompting companies to increasingly look East for trials. It’s a trend that some Congressional leaders see as a major threat to U.S. pharmaceutical dominance, one that has made modernizing U.S. trials more of a necessity than a wish.
Some measures outlined by HHS could speed the investigational new drug application process at the FDA, which Beca said would be a welcome change. One goal is to take the guesswork out of documentation requirements so companies know exactly what to include and can eliminate unnecessary information, which could be a major time-saver.
“The actual bottlenecks and the most punishing delays are self-inflicted by the industry through suboptimal protocol design."
Dr. Francisco Beca
Chief medical officer, QuantHealth
Another goal is to allow companies to tap into prior knowledge in areas such as manufacturing, so they don’t need to generate information independently each time.
HHS officials also want to cut down on unnecessary animal toxicology studies when appropriate and make trial protocols more flexible to reduce the need for time-consuming amendments.
The plan will establish a pilot program that uses professionals from qualified research institutions to guide sponsors in trial design and includes measures to remove barriers to patient participation.
The IND reforms, in particular, have the potential to shave six to 12 months off the timeline, according to HHS. But they aren’t necessarily a silver bullet, Beca said, because many of the biggest trial delays occur at the outset.
“The actual bottlenecks and the most punishing delays are self-inflicted by the industry through suboptimal protocol design,” he said.
Determining inclusion or exclusion criteria is one area that can generate lengthy internal discussions that negate any time savings the company might see from the streamlined FDA initiative, Beca added.
While the HHS initiatives may not solve every problem that slows research, broader changes to the regulatory apparatus aren’t misplaced, he said.
“Sponsors are reaching the conclusion that these legacy frameworks are not really working anymore,” Beca said, adding that this point is becoming even more true as trial complexity and costs rise alongside global price pressure.
But Beca noted it will be critical for agencies to ensure that the push for speed doesn’t erode safety and efficacy standards.
