The main purpose of the Pediatric Clinical Research Unit [PCRU] is to provide an optimal environment and resources which will enable investigators with a variety of interests to carryout clinical research projects. Research protocols are reviewed by the PCRU Advisors Subcommittee [including the biostatistician], the GCRC Advisory Board, Director, Associate Directors, Head Nurse and Dietitian for scientific merit and suitability for the PCRU. Details of the studies are reviewed with the Unit staff prior to implementation. Study progress is reviewed periodically by investigators with the PCRU staff and the covering House Staff. The PCRU also plays a major educational role in the Department of Pediatrics, providing seminars and lectures for medical students, house staff, post-doctoral fellows, and junior faculty, and providing opportunities for one-on-one interactions between investigators and house staff and medical students. A variety of studies are in progress and several new studies are being implemented: The Infectious Disease Division remains very active in a large number of ACTG HIV-related clinical trials, some of which have been designed at Hopkins, e.g. varicella immunization study. The Allergy/Immunology Division has expanded studies on immunopathogenic mechanisms of food hypersensitivity in several clinical disorders, and initiated new protocols focusing on asthma in inner city children and on the pathogenic role of aeroallergens [e.g. cat allergen, cockroach] in asthma. The Genetics and Metabolism Divisions are attempting to identify genetic markers and derive new therapeutic strategies, including gene insertion, for a variety of metabolic disorders including patients with gyrate atrophy, urea cycle enzymopathies, lipoprotein metabolism abnormalities and atherosclerosis, craniofacial disorders and achondroplasia. The Neurology Division continues to investigate new therapeutic approaches to congenital adrenoleukodystrophy [including gene therapy], and is further characterizing patients with Rett's Syndrome and attempting to define markers for this disorder. The Pulmonary Division is conducting a series of studies in patients with sleep apnea and other disorders [e.g. obesity], and will be instituting a gene therapy program in the upcoming year. The Gastroenterology Division is examining new markers and therapies liver disease in cystic fibrosis patients and the role of food allergy in gastroesophageal reflux. Studies by the Endocrine Division include evaluation of the utility of various biosynthetic hormones and the National Diabetes Prevention Program. Construction of the new facility for the PCRU will provide 5 inpatient beds, 3 outpatient examining rooms, a sleep study lab, and a gene therapy center, as well as ample work space, dietary facilities and a conference room, which will provide an environment highly conducive to clinical research and teaching activities. Investigators have been highly enthusiastic about the finalized plans, as demonstrated by a large increase in planned studies.
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