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What’s New in Pediatric Research: Recommendations From the National Academies of Science, Engineering, and Medicine

By Jennifer Lutz

In a major shift from previous guidelines, the National Academies of Science, Engineering, and Medicine are recommending that more children be included in more research, and at an earlier stage.

“We hope that the impact of the report is that children will be included in more trials and that individuals doing that research will be able to get funding,” says Frederick P. Rivara, vice chair for academic affairs and professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s, and cochair of the committee that wrote the report.

The report, “Strategies to Enhance NIH-Funded Pediatric Research,” was requested by the National Institutes of Health (NIH) after a mandate from Congress under the Biden administration. It was born out of necessity. According to the report, “Children in the United States are experiencing rising rates of chronic diseases and poor mental, emotional, and behavioral health. They are also 80% more likely to die than their peers in European nations.”

“I think those of us in the world aiming to make better lives for children see this consistent pattern, and it’s not just in health care or in research. It incorporates education, nutrition, housing—everything it takes to live a healthy and happy life—where children get the short end of the stick. And what that means is that we aren’t investing in the future,” says Sallie Permar, MD, PhD, chair of pediatrics at Weill Cornell Medicine.

“I think what it means for clinicians is that we need to change the way we’ve been communicating. What is the impetus for including children in this work rather than excluding them? And it’s about making life healthier for children,” she says.

Many studies have reported the rise of chronic illness in children, but health is down and mortality up in common infectious diseases, as well. The 2024–25 influenza season reported the highest number of pediatric deaths since 2004, when they became nationally notifiable.

“Child health has deteriorated in recent decades, and stronger investment in pediatric research could help reverse this trend. Historically, children have been underrepresented in clinical studies,” says Vittorio Gallo, PhD, senior vice president and chief scientific officer of the Seattle Children’s Research Institute, and coauthor of the report.

“They are not simply small adults. Their bodies, brains, and immune systems are constantly changing, and research designed for adults often fails to capture these differences,” Gallo says. “As a result, medications, diagnostics, and interventions can affect children in ways that are not fully understood. Recognizing these developmental differences is essential to advancing research that is both ethical and clinically useful.”

In a time of shifting priorities and tighter funding, the shift could have wide implications, not just for children, but for adults, too. “One of the things that we really talked a lot about in the report is the effect on the life course. If something occurs in childhood, people tend to think it just happens in a child, but it can have lifelong effects. For example, we know that being born premature can impact health into adulthood,” Rivara says.

Classification and Monitoring
A crucial obstacle the report tries to solve for is the classification and monitoring of pediatric research. Every NIH institute incorporates children into its mission in some way, but there’s a lack of crosstalk and coordination. The clearest recommendation in the report is to elevate pediatric research coordination, placing it directly under the NIH director to set NIH-wide pediatric research priorities. While the report recommends key changes, it does not offer clear guidelines on how and when to include children in studies. Rather, it’s a frameshift: protecting children through research, rather than from research.

“It’s important to stay focused on the mandate, which is to better understand how pediatric research is funded and how it will be better served with the information in this report,” says Phyllis Dennery, Sylvia Kay Hassenfeld Professor and chair of pediatrics at Warren Alpert Medical School of Brown University, and cochair of the committee that wrote the report.

“It’s a time of change, with many changes, and I think it’s very important that there is still resilience around pediatric research,” she says.

What direction pediatric research will take under the current administration is yet to be seen; some worry politics could limit inclusive studies, while others are optimistic that children will be ethically included.

“Priority areas should include mental health, neurodevelopmental disorders, obesity, asthma, autoimmune conditions, and other chronic illnesses that shape long-term outcomes,” Gallo says. “Longitudinal, real-world and community-based studies will be especially important. At the same time, there are valid reasons to exclude children from certain research, such as when risks outweigh benefits, when sufficient adult data is lacking, or when ethical protections cannot be fully ensured.”

It will take time and dedication to properly implement the recommendations, but the shift in approach is a monumental change in how research views pediatrics. “The vision chapter in this report speaks to the optimism that we see in the future, with a willingness to invest in pediatric research and to support the involvement of children in studies. We have the opportunity to reverse the deterioration that has happened in children’s health over the years,” Dennery says.

— Jennifer Lutz is a freelance journalist who covers health, politics, and travel. Her writing has appeared in The Guardian, The Independent, New York Daily News, BuzzFeed Politics, The Local ES, HealthCentral, Today’s Geriatric Medicine, Medscape, Pittsburgh City Paper, and more.