On December 4, 2012, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will stage its annual meeting to review the prioritization list of drugs to be studied under the Best Pharmaceuticals for Children Act (BPCA). The Pediatric Trials Network (PTN) will be a key participant in this meeting as it comprises the mechanism through which these prioritized drugs are studied and new labeling recommendations made.
The BPCA priority list consists of key therapeutic needs in the medical treatment of infants, children, and adolescents. The list is organized by therapeutic area, which can be a group of conditions, a specific population, or a setting of care. Each calendar year, a few therapeutic areas are selected for discussion and further prioritization.
Prioritization is based on three major considerations:
- Therapeutic gaps in pediatrics, which may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials
- Particular pediatric diseases, disorders, or conditions for which more complex knowledge and testing of therapeutics may be beneficial in pediatric populations
- The adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators
The NICHD established the PTN in September 2010 to provide an environment and an infrastructure for conducting safe and effective pediatric clinical trials for the BPCA drug development program. The BPCA priority list is revised every three years and informs the work of the PTN.