Informed Dosing = Better Care for Children
PTN research addresses knowledge gaps in the use of medications for pediatric patients. By 2017, the PTN expects to submit pediatric data for >20 products to the FDA.
Here we explore examples of some of the many ways in which PTN studies are informing better care:
- 1 in 10 US infants is born prematurely
- Our research has shown that the smallest babies sometimes need higher medication doses due to their immature organs
- PTN studies for this vulnerable population include
- Preventive therapies for bronchopulmonary dysplasia, a chronic lung disease affecting ~17,000 US infants per year
- Medications for potentially life-threatening infections
Children With Obesity
- About 1 in 5 US children is considered obese
- These patients are often excluded from clinical trials due to differences in the way their bodies handle drugs
- A PTN systematic review found only 20 studies that have examined drug pharmacokinetics in obese children
- Our studies evaluating dosing guidelines for obese children include
- Antibiotics for methicillin-resistant Staphylococcus aureus (MRSA) infections, the leading cause of hospitalization among US children and adolescents
- Antiseizure medications
Innovations in Pediatric Trial Design
- Advanced pharmacokinetic modeling
- Cutting-edge blood sampling methods
- Leftover samples from other laboratory tests
- Mining existing clinical data
Every PTN study is closely examined to determine how to obtain the most valuable and generalizable results while minimizing the risk to participants.
Matthew Laughon, MD, MPH, of the University of North Carolina at Chapel Hill, discusses innovative clinical trial designs used in the Pediatric Trials Network.
Physicians rely on treatment guidelines and reference materials to use the correct dose of medications for children. Through partnerships with the FDA and the American Academy of Pediatrics, evidence from PTN research is carried into product labeling and treatment guidelines, and ultimately, into the hands of physicians.
- Learn more in “Putting an End to ‘Ballpark Dosing’ in Children”