Best Pharmaceuticals for Children Act (BPCA)
The objective is for the BPCA project to manage multiple clinical trials for NICHD that will generate adequate safety and efficacy data for assigned regulated products, and assist NICHD in submitting the data to regulatory authorities for review and possible labeling changes.
Infants and children
Multi-center protocols with sites throughout the United States and in Canada
EMMES as the BPCA Data Coordinating Center (DCC) manages National Institute of Child Health and Human Development (NICHD)-sponsored pediatric research protocols.
Through a mandate from Congress, FDA and NICHD are working to improve the pediatric labeling of drug substances already on the market. The ultimate program goal is to provide practitioners with adequate labeling for the pediatric use of marketed medical products (if indeed this is not otherwise contraindicated) and thus improve the safety and efficacy of the drug substance for the affected population. Indeed, knowledge that a drug substance or a particular formulation may have no safe use in children is just as important to place in the labeling as the proper dosing and formulation for children should it be indicated. FDA, NICHD and other parties have agreed on a list of priority drug substances to research. NICHD contracts with investigators to pursue the priority research, and the DCC supports the funded research efforts under the BPCA project.
In brief, EMMES is responsible for developing trial design, collecting and analyzing trial data, monitoring data quality, collecting and preparing safety reports, organizing and submitting documentation to regulatory authorities like FDA, managing the Data Monitoring Committee (DMC), and providing for overall clinical trials management.