GENERAL CLINICAL RESEARCH CENTER

Duke University Medical Center requests continuing support for its General Clinical Research Center. This center consists of a hospital inpatient ward, an outpatient clinic, a metabolic kitchen, a sample- processing core laboratory, and a research environment for controlled observation and timely collection of patient samples including blood, urine, and other specimens as needed. Use of any of the components of the center by a physician-investigator requires approval of the GCRC Scientific Advisory Committee and approval of the Institutional Review Board for Clinical Investigations. All Duke University medical Center faculty with hospital admitting privileges Are eligible to submit protocols to the Scientific Advisory Committee. The diversity of protocols is reflected in the variety of departments of the principal investigators, which include the Departments of Medicine, Obstetrics and Gynecology, Pediatrics, Psychiatry, Surgery, Radiation Oncology, Anesthesiology, and Engineering. There is substantial collaboration among clinician-investigators in the clinical departments and between GCRC investigators in clinical departments and complementary basic science departments. The GCRC is the site for training medical students, house officers, and post-doctoral fellows in the latest research methodology. Also included in this application are a description of accomplishments since the previous site visit, a complete center infrastructure to support somatic cell and gene therapy protocols, encouragement of the interdisciplinary nature of clinical research, and renovation of our current facilities. A major initiative of the past three years has been to facilitate and support the transition of somatic cell and gene therapy research efforts into clinical trials. The position of Laboratory Consultant was developed and, in collaboration with the Department of Surgery, a Cellular Core Laboratory established to provide a "good laboratory practices" (GLP) environment for processing cells used in clinical trials. This initiative has been quite successful, as evidenced by the number of GCRC approved protocols and patients treated utilizing these novel therapies. With support of the GCRC, Duke University Medical Center investigators will continue to bring the latest advances in basic research to the beside in a multi disciplinary approach to the health and disease.