NIH is ending a key grant for budding clinical researchers

From ScienceMag:

Lilia Cervantes was a few years into her career as an internal medicine physician at a Denver hospital when she lost a patient who had become a friend. Hilda was an undocumented Mexican immigrant with kidney disease who did not have health insurance and could only get dialysis weekly at emergency rooms. She died in 2014, leaving behind two young sons. Cervantes felt the injustice of her death. “I decided I needed to learn to do research,” she says.

Cervantes later won an early-career development grant from the National Institutes of Health (NIH) that would pay enough of her salary that she could spend 75% of her time studying barriers to dialysis for Latino people. The grant also funded a small study within this group investigating whether meeting regularly with a community health worker could improve their health by spurring them to get the blood-cleaning procedure more often. The work helped Cervantes—now a professor at the University of Colorado—fall in love with clinical research.

But that grant mechanism will no longer fund trials, she learned at a May meeting of an NIH advisory board she sits on. She’s “devastated,” Cervantes says, noting that she is not speaking for that board or her university. “I’ve lost so much sleep.”

Some NIH staff are also alarmed by the move. “It cuts off a critical training pathway for clinical scientists,” a scarce part of the biomedical research workforce, says Jenna Norton, an NIH program officer who has protested many recent changes at the agency and is speaking in her personal capacity. But others argue the career development awards—NIH makes about 90 of these K grants each year—are not the best use of the agency’s budget, as they only provide enough funding for small, exploratory clinical studies that lack statistical power.

NIH this week announced the ban on clinical trial funding for K award recipients as part of an effort to simplify the grants meant to help early- and midcareer researchers who have mentors become independent investigators. Starting in July 2027, the awards can still be used to gain clinical trial experience in a study led by a mentor, but not to directly fund any clinical trials. The change is intended “to better align K awards with their primary purpose of career development,” the notice says. If a K recipient wants to run a trial, they must find other funding from NIH or sources such as foundations.

The agency is seeking input on “additional strategies” to support budding “scientists who can lead rigorous clinical trials,” the notice adds. Another notice seeks input on two options: a special type of clinical research grant that would be paired with a K award, which would still pay for the person’s salary and mentoring; or a two-stage award broken into a mentored portion, then a research grant. Both would allow new clinical investigators to conduct “studies with greater complexity, rigor, and statistical power,” the NIH press office said in response to a request for comment.

Some NIH observers remain concerned that jettisoning the K clinical trial awards is a mistake. Jeremy Berg, former director of NIH’s basic research institute (and former editor-in-chief of Science), has examined K grants made from 2010 to ’20 to see how many awardees went on to win an R01, the main type of NIH research grant. He found that about 23% later received an R01 for a clinical trial—more than twice the frequency as in the much larger group of nonclinical trial K awardees.

“If I were looking at this [program], I would be pretty close to dancing on the table that this was a huge success,” Berg says.

Berg also worries that marginalized groups and certain research topics may be disproportionately harmed. Almost two-thirds of those receiving the K clinical trial awards were women, and much of the funded research centered on studies on HIV, women, and behavioral research, according to a grant wording analysis conducted by Berg. Those areas “are all things that [President Donald Trump’s] administration is generally not very enthusiastic about,” he says.

Michael Lauer, who stepped down as NIH’s extramural research chief in early 2025, is among those who support the new NIH policy. He says the K clinical trial awards came up 10 years ago when NIH officials took steps to address what they described as too many “small, crappy clinical trials.” They changed standards for NIH trial funding in multiple ways but in the end left those particular K awards alone.

But Lauer’s glad to see them go now. Even small studies with human volunteers “should be directed by experienced people,” he says. In his field of heart disease, Laurer notes that he’s always advised early career researchers to get experience with the large, multiskilled teams that conduct major clinical studies and eventually move up to leading trials.

Cervantes responds that K awards still entail oversight by established investigators, but the type of research on getting proven treatments to patients that she conducted is done by smaller teams within real-world clinics and hospitals—not by the big clinical trial organizations Lauer has in mind. “My concern is that this [eliminating the awards] will lead to further attrition” from this part of the clinical researcher pipeline, she says.

NIH is taking comments on ways to support early-career clinical researchers until 30 September.

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