When the NIH took the unprecedented step of terminating almost 700 research grants and slashing more than $1.8 billion in funding for projects that didn’t align with the Trump administration’s priorities, vulnerable communities felt the initial blast the most.
Many of the research grant cuts made between February and April affected studies overseen by the National Institute of Mental Health and the National Institute on Minority Health and Health Disparities.
“There were cuts to research related to diversity, equity and inclusion, transgender or gender-related issues,” said Gary Zammit, founder of Clinilabs, a central nervous system-focused clinical research organization. “It also brought cuts related to minority health concerns.”
Many patients were left in the lurch, according to a recent research letter published in JAMA Internal Medicine. Hundreds of trials ground to a halt, displacing 74,000 participants, many of whom were already enrolled and taking investigational medications or living with an implanted device.
And these cuts created a major logistical challenge for researchers, trying to determine how to, and if they can, save their work. The job became particularly more difficult in studies where they employed researchers whose salaries were withdrawn when the grants were canceled.
The sudden cuts also upended traditional strategies where, most often, administrations shape scientific priorities through grant approvals, not by reversing funding, Zammit said.
Picking up the pieces
When a trial ends abruptly, the scientific team can’t just close the door and walk away, said Zammit. They need to protect the safety and welfare of participants by helping them transition either to a new caregiver in the community or through a referral to a new clinical trial.
If a patient is already taking an investigational medication as part of the trial, the transition process can become even more complicated.
“There are some medications that we can’t just abruptly discontinue,” he said. In these cases, drug withdrawals may require ongoing safety monitoring using blood tests or imaging.
Among the NIH terminations were a large number of infectious-disease trials and some cancer studies. Some experts recommend creating exit plans for complex trials, such as those involving implants, to help ensure an organized response to a surprise closure that could bring substantial patient risks.
Beyond patient-related responsibilities, researchers also must scramble to salvage the data they’ve already collected. Proper data analysis and careful closure of datasets are critical to preserving the scientific value of a terminated trial to ensure the information remains useful and credible for future research. Ensuring data quality is also crucial if researchers are looking to find alternate funding.
If researchers can’t find a way forward, it may spell the end of research that could have improved patient care and laid the early scientific groundwork for future commercial drugs. For some scientists, the terminated trial may represent a lifetime of work.
Beyond immediate operational challenges, Zammit and other experts see broader and significant risk in post-approval cuts, including patient harm, threats to research integrity and setbacks for long-term scientific progress.