This proposal requests continuing support for the General Clinical Research Center of Duke University Medical Center. This center, known at Duke as the Rankin Clinical Research Unit (CRU), consists of a hospital inpatient ward, an outpatient clinic, a metabolic kitchen, a sample- processing core laboratory, a computerized database management and analysis (CDMAS) system, and other ancillary services. It provides an atmosphere for controlled observation and timely collection of patient samples including blood, urine, bacteriology cultures, etc. A new initiative described in this application is the creation of two new Core Laboratory facilities (called the Cellular and Vector-Production Core Laboratories) which will facilitate transfer of new cellular and genetic technologies to clinical trials. This initiative will allow the Rankin CRU to remain at the forefront of clinical research at Duke, and indeed this initiative will speed the development of clinical protocols using new forms of therapy. Use of any of the components of the center by a physician-investigator requires approval of the Clinical Research Unit (CRU) 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. Current protocols have principal investigators from Medicine, Obstetrics and Gynecology, Pediatrics, Psychiatry, and Surgery. There is substantial collaboration among clinician-investigators in the clinical departments and between CRU investigators in clinical departments and complementary basic science departments. The CRU also is the site for training medical students, house officers, and post doctoral fellows in the latest research methodology. Included in this application is a description of accomplishments since the previous site visit, a complete center bibliography, a description of the program conducted by the center, and future plans.
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