Medical researchers baffled by Trump administration’s stop work order for clinical trial system: ‘A giant step backwards’

A national initiative used by 1,350 universities and academic medical centers to allow urgent clinical trials to move forward with speed, efficiency, and proper oversight has been handed a stop work order from the Trump administration. The move threatens to delay thousands of human studies on everything from cancer to dementia.

“We were told to cease all work…immediately,” an April 22 statement on its website reads, in part. “The order did not include a reason or explanation.”

The stop work order came around the same time that other orders—ending contracts on grants looking into conditions ranging from ALS to acute radiation syndrome—began rolling into Harvard. That was just hours after Harvard rejected government demands that included changes to governance and hiring practices and “audits” of viewpoints, noted the Harvard Gazette.

Of the stop work order, Dr. Barbara Bierer, director of the system known as SMART IRB (streamlined, multisite, accelerated resources for trials institutional review board), tells Fortune, “People were really shocked. We were, I have to say, not anticipating this at all.” 

The system, funded by a $2 million annual federal contract from the National Institutes of Health (NIH), was created by researchers at Harvard University 15 years ago to tackle two issues: to ensure proper protections for the human patients participating in large clinical trials, and to make sure those oversights did not slow down the study from getting underway. Typically, without SMART IRB, it could take many months to get a large clinical study up and running; with the system in place, it can happen as quickly as within 20 minutes.

“We want to bring new treatments to people that need them as quickly as possible,” says Bierer. In a not-yet-published op-ed shared with Fortune, she wrote of the stop work order, "We had taken 15 years to build what was destroyed with a single email, halting vital research across the country."  

Plus, Bierer told the Gazette, "Studies halted midstream risk significant harms to participants and communities and can reinforce public skepticism and mistrust for the research enterprise and inhibit the commitment of researchers and institutions to fully, honestly, and collaboratively work with the communities they serve."

At the height of the pandemic, SMART IRB enabled more than 300 COVID studies to quickly get off the ground.

“The numbers are remarkable considering that when the COVID-19 pandemic began, science and medicine needed to pivot at lightning speed to meet the challenge, and that’s not something biomedical science is known for, especially when it comes to translating hot-off-the-bench scientific discoveries into evidence-based clinical tools at the bedside,” explained a 2023 Harvard Medical School article. 

One big obstacle when it comes to multisite clinical trials getting underway quickly is that institutional review boards (IRBs) must take due diligence to make sure human research participants are protected, a process that could take nine months or longer. “But at the height of the pandemic,” the news release notes, “the science needed to advance knowledge of SARS-CoV-2 couldn’t wait that long.” Luckily, SMART IRB meant it didn’t have to.

But now, because of the inexplicable stop work order, says Bierer, “instead of a coordinated system that advances research, we are taking a giant step backward and compromising the very research that would improve the health of all Americans.”

It’s further baffling, she says, as “the people that we work with at NIH have been the best collaborators you can imagine. They're responsive, they're helpful. They took over the IT side of this, because they could do it more effectively and integrate it with other systems that they have going…They were very enthusiastic about this and, you'd have to speak to them, but I think equally surprised.”

The NIH responded to Fortune’s request for comment simply by noting, “In accordance with the Presidential Memo ‘Radical Transparency About Wasteful Spending,’ information on NIH’s terminated grants may be accessed through this website,” also including a link to a chart of all grants terminated thus far. 

In the meantime, as the system itself remains available, Bierer says employees of Harvard—which doesn’t own the collaborative system, but administers it—have been temporarily supported by Harvard, in lieu of NIH funding, to keep it going, answering help desk questions and just assisting researchers move through SMART IRB process to keep trials up and running. Though it’s uncertain how long they’ll be able to keep it up. 

“What the Trump administration says it wants to do is to make the government more efficient, and get rid of challenges that don't necessarily improve the lives of Americans,” Bierer says. “But this really does exactly that. It does make the government more efficient and does improve the lives of all Americans. It takes away these months of delays.”

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This story was originally featured on Fortune.com