The Duke Clinical Research Institute (DCRI) has been awarded a competitive renewal to lead the Pediatric Trials Network (PTN), extending a program that has reshaped how medicines and medical devices are studied and approved for use in children since its founding in 2010.
The network, now entering its third iteration as PTN 3.0, spans more than 100 clinical research sites across the country and has enrolled more than 13,500 participants in 54 studies, generating more than 200 publications and contributing to 26 pediatric label changes with the U.S. Food and Drug Administration.
Children differ physiologically from adults. The way drugs are processed in young patients is affected by developing organs and metabolic changes throughout infancy and childhood. Therefore, therapies that are safe and effective in adults cannot simply be assumed to work the same way for children.
Yet, just a small percentage of FDA-approved drugs and devices bear pediatric-specific labeling. In the absence of evidence generated from children’s studies, pediatricians are often left prescribing medications "off-label" and must rely on their best clinical judgment.
PTN closes this gap by focusing on off-patent drugs, generating safety, efficacy, and dosing data to update pediatric drug labels and guidelines.
The network is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as a result of the Best Pharmaceuticals for Children Act (BPCA). Danny Benjamin, MD, PhD, MPH, and Rachel Greenberg, MD, MB, MHS, serve as the network's principal investigators.
“This renewal reflects years of disciplined collaboration and scientific rigor, all focused on closing critical evidence gaps for children and ensuring pediatric care is informed by data from trials designed specifically for them,” said Greenberg.
The DCRI first received the PTN award in 2010. A competitive renewal followed in 2018, and the latest award reflects the DCRI's continued scientific leadership over a 15-year span. Throughout the lifecycle of the network, the DCRI has been the PTN’s clinical coordinating center, leading the design, execution, and regulatory translation of the PTN’s many studies.
PTN research has led to label updates for medications used to treat infections, seizures, high blood pressure, and pain in infants and children, such as acyclovir, clindamycin, fluconazole, levetiracetam, lisinopril, lorazepam, meropenem, metronidazole, oxycodone, and topiramate. The network’s efforts also extend to developing pediatric-specific medical devices.
"Receiving the competitive renewal for the Pediatric Trials Network is incredibly meaningful given how essential this work is for children who rely on medications every day," said Cheryl Alderman, a PTN program manager. "Being part of a network that has already contributed to 26 pediatric label changes is something I'm very proud of, and I'm excited to keep supporting the operational work that turns critical data into meaningful regulatory impacts for children's health."
PTN 3.0 will maintain its mission of conducting high-quality pediatric drug and device studies, leveraging established infrastructure to enable efficient research and improve clinical care.
More information about the Pediatric Trials Network, including a full list of studies and results summaries, is available at pediatrictrials.org.