Pediatric drug trials are needed but perceived as difficult to performed. Yet, Children's Hospital, Columbus has successfully completed hundreds of trails by providing the resources necessary to overcome the ethical, financial, and practical problems associated with such studies. Previously available resources included: a) active Clinical Pharmacology and Clinically Pharmacy Divisions, b)a pediatric Clinical study Center (CSC), c)a pediatric pharmacy compounding unit, d) investigators with proven track records conducting pharmaceutical research, e) a large pediatric academic training program, f) a dedicated administrative and scientific support staff and structure, and g) access to a large, representative study population. To this have been added additional NIH supported clinical and basic scientists with sophisticated technology (e.g. stable isotope mass spectroscopy), al in a vibrant, well-designed, spacious research and tertiary-care clinical facility with well coordinated community, hospital, and academic support. A plan is proposed to take advantage of NICHD funding to build on this success by reorganizing these resources into a pediatric pharmacology research unit (PPRU) linked, along with other PPRU's as a """"""""Network"""""""" to the NICHD. This Network would provide training and serve as a resource to federal, pharmaceutical, and other entities for conduction studies developed by consensus of the units; both pharmaceutical, and other entities for conducting studies developed by consensus of the units; both pharmaceutical firm trials and investigator-initiated pediatric pharmacokinetic (PK) and pharmacodynamic (PD) studies. The Network would be in a unique position to respond to increasing public interest in pediatric drugs, growing regulatory and legislative pressure to study drugs in children, and growing industry, academic and government demand for pediatric pharmacologists. The objective is to increase the number and variety of medications that are FDA-approved for use in children, with the ultimate goal of providing the data necessary for all pediatric drugs to be labelled for use in infants and children. Available resources and previous clinical trial and training activates are reviewed to illustrate how the proposed PPRU would guarantee rapid progress toward this objective, consistent with the mission of the NICHD, and the need of practitioners and their pediatric patients. Specific examples are given of two completed pharmaceutical PH/PD trials, two ongoing investigator-initiated studies, and two PK/PD studies proposed for completion by the Network. The unique blend of resources available and the applicants' proven ability to conduct clinical trials in a variety of pediatric populations and conditions provides the NICHD the opportunity to """"""""leverage"""""""" its investment in a institution which has already identified pediatric pharmacology as a high priority. The proposed PPRU will enhance the pace of pediatric drug development, increase the number of pediatric pharmacologists, and improve both the amount and quality of pediatric pharmacology research.
