PTN was established in 2010 as part of NICHD’s efforts for the Best Pharmaceuticals for Children Act (BPCA) program to serve as a focal point for pharmaceutical clinical trials in pediatric populations. The network, which comprises more than 100 clinical research sites across the United States, including leading pediatric hospitals and academic and research institutions, is funded through NICHD’s Obstetric and Pediatric Pharmacology and Therapeutics Branch.
PTN’s main objectives are to:
- Provide an environment and appropriate infrastructure for conducting safe and effective pediatric clinical trials for BPCA
- Perform ancillary activities in support of these trials
- Provide an atmosphere for training junior investigators in writing and conducting regulatory rigorous pediatric drug trials
Currently, the U.S. Food and Drug Administration (FDA) labels only a small percentage of drugs and devices for pediatric use. Pediatricians too often must prescribe medical therapies “off-label,” or according to best guesses based on adult studies.
BPCA was created to address this problem and to improve the available data related to medication use in children. PTN helps further the activities of
BPCA by conducting trials primarily with off-patent drugs with no data on use in pediatric populations.
Data collected from PTN trials help regulators revise drug labels for safer and more effective use in infants and children. The BPCA website provides a list of accomplishments related to BPCA pediatric labeling changes.
PTN studies the formulation, dosing, efficacy, and safety of drugs in pediatric populations. The network also addresses the development of medical devices specifically for pediatric patients. Among the therapeutic areas PTN focuses on are:
- Cardiovascular diseases
- Infectious diseases
- Respiratory diseases
Visit https://pediatrictrials.org/ptn-studies/ for a listing of congoing and completed PTN studies.