The Yale School of Medicine and Department of Pediatrics provide an optimal environment for a Pediatric Pharmacology Research Unit. This application for a Pediatric Pharmacology Research Unit (PPRU) at the Yale University Department of Pediatrics draws upon the expertise and resources of the department as well as the Medical School, including the Dean who was the former director of the FDA, the chairman who is also Deputy Dean for Clinical Affairs and supervises the Clinical Trials Office and the PI who directs the Children's Clinical Research Center. Full-time faculty in the Department are leaders in their clinical disciplines and have a long and distinguished record of achievement in extramurally-supported clinical research activities. Patient care and clinical research efforts have been greatly enhanced by the new Yale-New Haven Children's Hospital and by the new Child Health Research Center facilities. In addition, are the resources of the established a Community Pediatric Pharmacology Network made up of area pediatricians who hold clinical faculty appointments. Most important, the leadership of the PPRU is strongly committed to making the program an unequivocal success. The PPRU will have an overall responsibility for the conducting of clinical trials and clinical research studies by investigators in the PPRU. A general summary of these responsibilities includes: support of Yale investigators in generating trials including design, statistical issues, data collection forms, electronic data base and submission to the oversight committees, nursing support for patients participating in clinical trials including assuring adherence to protocol mandates, assessment of patients for toxicity, response evaluation and obtaining informed consent, assisting PPRU investigators in following all applicable rules and regulations governing clinical trials, providing a venue, the Community Pharmacology Network (CPN), in which clinical trials initiated by PPRU investigators can be effectively and expeditiously conducted.
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