Clinical trials face uncertain futures amid Trump cuts

For kidney transplant recipient Janet Handal, the recent push to phase out COVID-19 research could have a deadly outcome. 

In early 2021, Handal participated in a study that found almost half of organ transplant recipients had no immune response to two doses of an mRNA COVID-19 vaccine. The finding came at a time when most people were celebrating that two shots could help them safely re-enter the world.

“For people that are immunocompromised [from] the treatments, [the vaccines] don’t have the same effect,” says Handal, president and cofounder of the Transplant Recipients and Immunocompromised Patient Advocacy Group. The drugs that prevent their bodies from rejecting foreign organs interfere with the protective responses typically elicited by the jabs.

The study, published June 2021, paved the way for a research project involving three clinical trials investigating how to improve COVID-19 vaccine responses in transplant recipients. While results from one trial were published in 2023, the other two are now in peril.

On March 24, the U.S. National Institutes of Health — the world’s largest public funder of biomedical research — suspended funding that had been awarded to complete final analyses of the trials’ data. Termination notice language shared with Science News states “now that the pandemic is over, the grant funds are no longer necessary.” Dozens of other COVID-19 researchers received the same message, although some have recovered their funding.

Amid upheaval targeting transgender health, vaccine hesitancy and more, NIH is ripping away research grants, reportedly halting more than 100 clinical trials. The sweeping cuts, which the Trump administration claims will reduce government spending, have also upended clinical trials globally.

“The administration has decided to impose their values and their words in people’s research projects — and that’s not up to them,” says Georges Benjamin, executive director of the American Public Health Association. The organization is among several suing NIH, declaring the mass termination of grants unlawful and demanding their restoration. Disrupting clinical trials and other biomedical research could have ripple effects for everyone, he adds. “Even though you may not have a disease, someday you may, and so you lose the potential opportunity of a cure when you do.”

To learn more about the impacts of the Trump administration’s defunding of clinical trials, Science News spoke to researchers involved in studies forced to cease operations at three different stages. NIH did not respond to a request for comment.

Women are left out of an STI treatment

Infectious diseases physician scientist Jenell Stewart was about to launch a nationwide clinical trial when her funding vanished. The trial aimed to test whether a well-known antibiotic could prevent sexually transmitted infections after exposure in female adolescents and young adults.

Called doxycycline post-exposure prophylaxis, or doxyPEP, the treatment has proven effective in people assigned male at birth. The U.S. Centers for Disease Control and Prevention recommend it as a preventive measure for gay, bisexual and other men who have sex with men and transgender women. In that group, doxyPEP reduces the risk of chlamydia and syphilis by about 80 percent or more, and gonorrhea by around 60 percent.

“But women are left out,” says Stewart, of Hennepin Healthcare in Minneapolis.

This month, Stewart and her colleagues were set to start enrolling about 760 cisgender women ages 13 to 29, following each for one year. One-third would have on-demand access to doxyPEP after a sexual encounter, another third would take it weekly regardless of sexual activity, and the rest would receive quarterly testing for infections and treatment with counseling, which is the current standard of care.

But on March 21, the research network supporting the study — the Adolescent Medicine Trials Network for HIV/AIDS Intervention, or ATN — lost its grant funding and was terminated. A letter from NIH shared with Science News states “research programs based primarily on artificial and nonscientific categories … do not enhance health, lengthen life or reduce illness.”

In its 24-year history, the ATN has enrolled more than 30,000 adolescents and young adults in over 150 studies, says HIV/AIDS researcher and ATN co-leader Lisa Hightow-Weidman of Florida State University in Tallahassee. Some of that research helped pre-exposure prophylaxis, or PrEP, medications get approval as an HIV prevention method in adolescents.

Ending the ATN is “just so illogical,” Stewart says. “It doesn’t make economic sense. It doesn’t make ethical sense. There’s not a lot of rationale behind an abrupt end to a study network, or a study like [the doxyPEP trial], especially where the current administration has stated goals of improving longevity and quality of life.”

The decision also conflicts with President Trump’s pledge during his first term to end the HIV epidemic in the United States. The cancellation disrupts seven clinical trials that were active or poised to launch by the end of the year, including some aimed at boosting HIV testing and PrEP adherence in adolescents, Hightow-Weidman says. She hopes the termination of the ATN was a mistake and has appealed the decision to try and restore funding.

Stewart’s doxyPEP trial — which she remains committed to completing regardless of the appeal outcome — could have provided rigorous data needed to demonstrate the treatment’s effectiveness in cisgender women. Doctors still offer the medication to them, stating that “it works really well for men; I think it’ll work for you,’” Stewart says. But “we haven’t seen very many women taking up that option, because it’s not very compelling to be told, ‘It should work; I’m not sure.’”

Postpartum care could ward off depression

In mid-March, 21 new moms were told they would no longer receive free care from doulas via phone and video calls. They had been enrolled in a clinical trial investigating whether doulas trained in cognitive behavioral therapy could help parents stave off postpartum depression and improve heart health. Study participants identified as Black, Latino or were on Medicaid.

“We made a promise to these people,” so abruptly ending is unethical, says reproductive psychiatrist and clinical researcher Lauren Osborne of Weill Cornell Medicine and NewYork-Presbyterian Hospital.

She received word on March 10 that the New York City–based clinical trial — a collaboration between Cornell, Columbia University and several community health organizations — would stop because the Trump administration canceled $400 million in federal funds to Columbia. That’s because of protests over the Gaza war and what the government describes as failure to control antisemitism. The university is complying with the administration’s demands, including banning protests inside academic buildings and appointing an official to review programs related to the Middle East, in an effort to restore the money.

Osborne doubts Columbia will recover funding to resume her clinical trial. But about a week after it was terminated, she secured funding from Cornell to continue providing care to the already-enrolled participants. Some decided to drop out because of the uncertainty caused by the back-and-forth. Those who remained will continue receiving care from doulas — either a therapy-based intervention or more general health education on topics like breastfeeding — for six months after giving birth.

“It’s not going to give us any useful research material, but it completes that ethical obligation to our participants,” Osborne says. The trial was supposed to include about 600 postpartum individuals and last for more than five years. Osborne plans to apply for other NIH grants to restart it in the future, though she notes that clinching an award will depend on the agency’s funding priorities.

“We do a shockingly bad job of treating postpartum depression in this country,” Osborne says. “Only about 3 percent of women with postpartum depression are actually treated all the way to remission.”

That’s largely because there aren’t enough people trained to recognize the signs, she says. The clinical trial involving doulas would have helped determine whether non–mental health specialists could intervene in a relatively low-cost way. Mental health conditions and cardiovascular problems are leading causes of pregnancy-related deaths in the United States, whose maternal mortality rate is worse than that of most other high-income nations.

Beyond obstructing better care, halting studies can erode community trust in clinical investigators, Osborne says. That hard-fought trust is difficult to gain, especially since the United States has a history of racist and other unethical research practices. “Building those relationships with the community is really hard,” Osborne says. “We’ve now done a lot of damage to that relationship by saying we are not a reliable partner.”

Immunocompromised people need better protection from COVID-19

The clinical trials that followed the research involving transplant recipient Handal had about four months of remaining funding when turmoil began. NIH terminated funds for the COVID-19–related research on March 24. But a court-ordered temporary restraining order filed on April 5 barred the U.S. Department of Health and Human Services — NIH’s parent agency — from abruptly ending crucial public health funding in the 23 states and the District of Columbia that sued. The order expires on April 17, when a hearing will take place.

NIH stated that the money for the two trials trying to better protect organ transplant recipients from COVID-19 was not needed because the pandemic is over. That is “an ignorant statement,” Handal says. “COVID continues to evolve.… It’s not over. And it is for sure not over for people that have a compromised immune system.”

All participant data have been collected, and the two trials “were in the final stage of analysis,” says infectious diseases physician scientist Christine Durand of Johns Hopkins Medicine. The abrupt terminations may limit what researchers can learn from these multiyear projects. Durand can use her awarded funds until the restraining order ends.

One clinical trial that started in 2021 had enrolled 48 kidney or liver transplant recipients. Durand and her colleagues were investigating whether temporarily reducing participants’ immunosuppressive drugs, which prevent organ rejection, could boost their protective immune responses to an mRNA COVID-19 shot. The other trial, which began in 2023, included around 80 kidney transplant recipients to see if a specific COVID-19 vaccine — one developed by pharmaceutical companies Sanofi and GSK — could elicit better immune responses in people who didn’t retain protection from an mRNA version.

For organ transplant recipients, COVID-19 remains deadly. “We need to do better in terms of finding better strategies to protect people from getting it,” Durand says. “Most of us know someone in our lives who has had a life-saving organ transplant, and the most common cause of death for those people are infections.”

If Durand fails to get her original funding back, she plans to pivot. “I’ll look for alternative sources of funding. I’ll see what we can publish from the data and the assays that were completed to date,” she says. “Our team will do everything we can to maximize what we can learn.”

Meanwhile, Handal worries about losing the foundation for future research that could help keep everyone, not just immunocompromised people, safe from emerging and future pathogens. “The cuts at NIH have just been devastating,” she says. “All this work that’s been done — and remains to be done — it just comes to a standstill.”