Pediatric drug trials are needed but are difficult to perform. Yet, Children's Hospital, Columbus has successfully completed hundreds of trials by providing the resources necessary to overcome the ethical, financial, and practical problems associated with such studies. Resources which are available include: a) active Clinical Pharmacology and Clinical Pharmacy Divisions, b) a Pediatric Clinical Study Center (P-CSC), c) a Pediatric Pharmacology Research Unit (PPRU), d) a university General Clinical Research Center (GCRC), e) basic and clinical investigators with proven track records conducting pharmaceutical research, f) a large pediatric training program, g) a supportive administrative and scientific staff and structure, h) large, representative pediatric study populations, and i) sophisticated state-of-the-art technology. Resources are located in well-designed research space and tertiary-care clinical facilities with excellent community, hospital, and academic support. A plan is proposed to build on our past PPRU success by continuing as a member of an expanded NICHD pediatric pharmacology research """"""""Network"""""""". The Columbus PPRU would continue to provide training and serve as a resource to federal, pharmaceutical, and other entities for the planning, conduct, and analysis of pediatric drug studies. Pediatric bioavailability, formulations, drug metabolism, pharmacokinetic (PK), pharmacodynamic (PD), safety and efficacy studies would all be performed. The PPRU Network objective is to increase the number and variety of medications that are FDA-approved for use in children. The ultimate goal is to provide the data necessary for all drugs to be labeled for appropriate use in infants and children. Available resources, previous PPRU experience, as well as clinical trial and training activities are reviewed to illustrate how this PPRU would guarantee rapid progress toward this objective. Studies performed would be consistent with the mission of the NICHD and the needs of practitioners and their pediatric patients. A specific example is given of an analgesic/antipyretic trial proposed for completion by the Network to illustrate the ability of this PPRU to recruit sponsors, to design studies, to incorporate the unique strengths of individual PPRU Network members, and to maximize the scientific value of the results produced. The resources available and the applicant's proven ability to conduct pediatric trials in a variety of pediatric populations both provide the NICHD the opportunity to """"""""leverage"""""""" its investment in the Columbus PPRU. This would enhance the pace of pediatric drug development, increase the number of trained pediatric pharmacologists available, and improve both the amount and quality of pediatric pharmacology research produced.
