Amongst all the news about federal funding for scientific research being cut, about the government being sued over such actions once and twice again, one change has stood out to laboratory medicine professionals. After years-long, Herculean efforts by the scientific community to make sure that populations in clinical trials and other research protocols include the entire population, the Food and Drug Administration (FDA) abruptly removed draft guidance about such work from its website soon after President Trump was inaugurated in January of this year.
While the FDA hasn’t exactly barred efforts of scientists to continue making sure researchers are taking participants from different backgrounds, executive orders (many of which have been challenged in court) could make it difficult to do so. For example, the Trump administration’s order to terminate funding related to diversity, equity, and inclusion has led the National Institutes of Health (NIH) to cancel nearly 800 grants that it had previously awarded, according to
Nature. Many of these grants funded studies on populations that have historically been underrepresented in medical research, according to
Scientific American.
The Trump administration has defended the changes as necessary for improving efficiency and accountability in government spending. White House spokesperson Kush Desai told
NBC News that the Trump administration was “committed to slashing waste, fraud, and abuse,” and that “resources can’t be spent on advancing vague social goals.” Desai added that, “Contrary to the hysteria, redirecting billions of allocated NIH spending away from opaque administrative expenses means there will be more money and resources available for legitimate scientific research, not less.”
This effort to pare back on research focused on health equity has many laboratory medicine professionals worried about their work going forward.
“Unfortunately, right now science is under attack,” said Karen M. Winkfield, MD, PhD, Ingram Professor of Cancer Research at Vanderbilt Ingram Cancer Center in Nashville, Tennessee, professor of medicine at Meharry Medical College, and executive director of the Meharry-Vanderbilt Alliance, a strategic partnership between Meharry Medical College, a historically Black college, and Vanderbilt University Medical Center.
The importance of inclusiveness in clinical trial pools
In January, the FDA removed its previously issued draft guidance on inclusiveness in clinical trials. The guidance, which was originally released in June 2024, required sponsors to submit Diversity Action Plans that showed things like enrollment diversity goals and strategies to meet them; considerations on race and ethnicity for reporting; and representation of diverse age groups, including in pediatrics. It also required sponsors to identify barriers that might prevent them from reaching their stated goals. The final guidance was scheduled to be due on June 26 of this year.
“The absence of this guidance raises questions for sponsors about how FDA will consider clinical trial diversity data in Diversity Action Plans and in other submissions,” said Crowell, a law firm that specializes in regulatory and policy issues,
in a statement about the action.
While the guidance document has been taken down, there is still a federal requirement for the inclusion of women and underserved populations, said Winkfield. “The work continues,” she said.
The DEPICT (Diverse and Equitable Participation in Clinical Trials) Act, which was passed in 2022 and has not been repealed, requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and addresses related issues.
This is vital because diversity in clinical trials is crucial to making sure that healthcare and medicine is applicable to everyone, not just the traditional clinical trial study participants of mostly white men.
“It is essential for research to report on the composition of cohorts studied in terms of gender, sex, race, ethnicity, etc. to ensure equity in our studies and the validity of the resultant outcomes data and treatments,” wrote Nicole Tolan, PhD, DABCC, in a response to a survey that the Association for Diagnostics & Laboratory Medicine (formerly AACC) sent out to members asking how the current administration’s executive orders are impacting their labs and their ability to meet patient needs. Tolan added that it is also essential “to conduct research on health inequities based on these and other important categories such as socioeconomic status to improve outcomes and overall quality of care for all patients.” Tolan is an assistant professor of pathology at Harvard Medical School and the medical laboratory director of clinical chemistry, mass spectrometry section, point-of-care testing, and the home hospital program at Brigham and Women’s Hospital and Mass General Brigham in Boston.
Examples where it made a difference to look at how treatments affect different people differently are too numerous to count in terms of drug development, creating clinical guidelines, and testing drug assays. Just recently, for example, researchers at Rutgers discovered that
blood tests for Alzheimer’s may not be accurate for Black patients because of how they were validated. Researchers found that these validations had been largely done on the spinal fluid of white patients, even though the same biomarker in the spinal fluid of Black patients is generally lower.
“For Black patients, it’s a double whammy,” William Hu, MD, PhD, senior author of the paper in
Alzheimer’s & Dementia, said in a statement. "Not only will you have a harder time using these proteins in the spinal fluid to diagnose Alzheimer's disease in Black patients, you will further reduce the detection rate by relying on the blood tests." Hu is the director of the Rutgers Center for Healthy Aging Research in New Brunswick, New Jersey, and chief of the Cognitive Neurology & Alzheimer’s Disease Clinic.
Recruitment of diverse clinical trial pools continues
While the FDA draft guidance has been removed, work in creating those diverse clinical trial pools is ongoing, clinicians told us. Sunanda Gaur, MD, professor of pediatrics, director of adult and pediatric clinical research centers, and director of the South Asian Total Health Initiative at the Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, said that they have had success, and plan to continue to have success, through decentralized trials. “We’re taking the study to the community rather than having the person come into the research center. It helps a lot,” she said.
She also encourages researchers to think about health equity beyond race and gender and to look through a broader lens. “It’s about the elderly. It’s about children. It’s about people with disabilities. It’s about people in rural areas,” she said. “It’s about bringing everybody along.”
Winkfield said that community groups have been critical in bringing diversity numbers up in clinical trials, including local and national organizations that have heavy local presences like
TOUCH, the national Black breast cancer alliance, and
EFNEP, an extended food program in North Carolina.
“It is really important to make sure that you have local initiatives that can really help with supporting trial implementation and getting the word out,” she said, adding that a piece of paper “shouldn’t even need to be in existence” to encourage clinical trial diversity.
“If it’s ingrained in us, we just need to hold steady and still be intentional in our work,” she said.
While a barrage of changes have hit federally funded research, the private sector has pledged to stay the course when it comes to diversity in clinical trials.
According to a February story from Fierce Biotech, Eli Lilly, Bristol Myers Squibb, Sanofi, and Roche’s Greentech all confirmed they are dedicated to continuing advancing diversity in clinical trials.
“Lilly’s commitment to developing safe and effective medicines for all patient populations is unwavering,” a spokesperson told
Fierce Biotech. “We know that to meet our purpose of making life better for people around the world, we must design our trials so that we can test safety and efficacy for diverse patient populations.”
Sanofi echoed that position. “As a global company held to the highest standards of scientific integrity, Sanofi believes appropriate representation in clinical studies is crucial for ensuring that the efficacy and safety profile of all medical treatments developed are understood for all people,” a Sanofi spokesperson told
Fierce Biotech.
There’s also a business case for maintaining diversity in trials, Winkfield pointed out.
According to the National Institute on Minority Health and Health Disparities, racial and ethnic health disparities cost the U.S. economy $451 billion in 2018, a 14% increase from $320 billion in 2014.
Doing research amidst concern and fear
Despite the drive and commitment to continue to do work that leads to health equity, the reality of the current administration’s approach to scientific research can’t be kept separate from the work itself — or the people doing such critical science.
One clinical laboratorian at an academic research institution, who spoke on the condition of anonymity, said that the federal stance on scientific research has been “devastating,” and that the effects are far reaching. “It’s impacting care as a whole — drugs and clinical trials and investigation of drugs,” they said.
Such an anti-diversity stance in health and medicine is also affecting relationships researchers have been working to build with people who have traditionally not felt welcome in healthcare and who have felt shut out of being part of academic research, like members of the LGBTQ+ community. “If you don’t have clear guidance on how we should be recruiting diverse groups to participate in clinical trials through that FDA guidance, it will exacerbate those disparities,” the clinical laboratorian said.
They and their colleagues are being careful in how they talk about their work and their concerns with other people, for fear that the wrong person could hear something they don’t like and put them in jeopardy. This researcher specifically cited the arrest and possible green card revocation of
Mahmoud Khalil, a legal permanent resident of the U.S. who led Gaza solidarity protests at Columbia University, as a warning.
Many of the researcher’s colleagues are in the U.S. on visas and green cards. If those can suddenly be revoked from a student in New York, what’s to say that it can’t happen to a researcher doing work that the federal government decides it doesn’t like, they asked.
According to the
NSF 2024 Indicators Report, foreign-born workers made up about 19% of the U.S. STEM workforce in 2021, and more than one third of science and engineering doctoral recipients in the U.S. between 2018 and 2021 were here on temporary visas. If the federal government can suddenly decide who they want to deport, no matter their immigration status, academic freedom, including with respect to how researchers go about finding participants for clinical trials, is in peril.
“The whole atmosphere at the university right now is frightening,” they said.
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +X: @byJenAMiller
