Speaker
Perdita Taylor-Zapata, MD
Best Pharmaceuticals for Children Act (BPCA) Program Lead and NICHD Program Officer
Obstetric and Pediatric Pharmacology and Therapeutics Branch
National Institute of Child Health and Human Development
Keywords
NIH Best Pharmaceuticals for Children Act; Pediatric Trial Network; Trial design; Pediatric drug development
Key Points
- The current model for pediatric drug development can be slow and neglect neonates and rare pediatric conditions.
- The NIH Best Pharmaceuticals for Children Act (BPCA) allows the NIH to conduct clinical trials with off-patent drugs in children.
- Goals of the BPCA program include developing novel trial designs and including diverse and understudied populations.
- A new framework to enable pediatric drug development could identify resources to assist in drug development, identify areas in need of further research, provide a pathway for integrating approaches, and connect pediatric researchers.
- The BPCA went through a rigorous systematic approach to develop a comprehensive resource listing for best practices for pediatric drug trials.
Discussion Themes
Most data collected through the opportunistic model presented is PK data to determine dosing so that a more traditional drug trial can be conducted in the future.
With the right infrastructure in place, such as the Pediatric Trials Network, can substantially improve time to conduct trials.
Read more about the BPCA and their commitment to diversity in pediatric drug trials.
Tags
#pctGR, @Collaboratory1