S.3 Ep. 5 | Pediatric Dosing: Protecting Children Through Research, Not From It
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Hosts Emily O'Brien and Daniel Edmonston welcome Danny Benjamin, Deputy Executive Director of the Duke Clinical Research Institute and principal investigator of the Pediatric Trials Network, to explore why kids are not just small adults when it comes to medicine. Dr. Benjamin discusses why simply scaling a medication dose based on body weight can be catastrophically wrong about one-third of the time, as organs and drug-metabolizing enzymes mature at different, unpredictable rates. The hosts and guest trace how the field moved from protecting children from clinical research to protecting them through it, and how the Best Pharmaceuticals for Children Act reshaped pediatric drug study. Dr. Benjamin shares the origin story of the Pediatric Trials Network and explains how platform trials and minimal blood sampling have made it possible to study dosing for almost 100 medicines. This episode also explores lessons from setbacks, what adult trials can learn from pediatrics, and the safeguards parents should look for when considering a clinical study for their child.
Related Resources
- Grand Rounds July 24, 2026: The Pediatric Trials Network: Innovating to Make Drugs Safe and Effective for Children (Rachel Greenberg, MD, MB, MHS; Danny Benjamin, MD, PhD, MPH): Benjamin and Greenberg present the network's history, its platform trials, and lessons learned.
- Pediatric Trials Network: The network's home page, with study information, resources for researchers, and results summaries for families.
About Our Guest
Danny Benjamin, MD, PhD, MPH, is the Kiser-Arena Distinguished Professor of Pediatrics at Duke University and Deputy Executive Director of the Duke Clinical Research Institute. Board-certified in pediatrics and pediatric infectious disease, he leads research in clinical pharmacology, therapeutics, trials, and pharmacoepidemiology. Dr. Benjamin serves as principal investigator and chair of the National Institute of Child Health and Human Development's Pediatric Trials Network, which designs and leads clinical trials of off-patent medicines in children of all ages across all therapeutic areas. The network has established, or is actively studying, the correct dosing and safety of more than 100 of the most commonly used medicines in children. As an advisor to the U.S. Food and Drug Administration on pediatric clinical trial design, he held a joint appointment as a medical officer and special pediatric consultant.