In this proposal we request continuing support for the General Clinical Research Center (GCRC) at the University of Kentucky Medical Center. The GCRC supports ethical multidisciplinary clinical research by a large number of investigators across the University of Kentucky campus. The GCRC is the only clinical research center in the state of Kentucky, and it serves as a clinical research focus for multiple centers on campus and multidisciplinary programs. Since the last site visit, we have seen major growth in both the inpatient and outpatient activity of our center. We have had important scientific accomplishments that are outlined in this proposal. We have assumed an active role in teaching, and the GCRC serves as a focus for teaching clinical research to students from multiple disciplines such as Pharmacy, Nursing, Medicine and Allied Health. Our GCRC has moved into a new renovated space that is specifically designed for clinical studies. This 13 bed unit is physically aligned with our School of Pharmacy's Drug Product Evaluation Unit. This will enhance our critical mass of patients for teaching opportunities and will focus clinical research on one wing of the hospital. We are requesting a small core cytokine laboratory because of investigator demand for cytokine analysis, and we are requesting enhanced biostatistical support. Diverse investigators across campus working on unique and clinically important protocols utilize the GCRC. For example, Dr. Foon, Head of our Cancer Center, has a vaccine trial for breast cancer therapy. Dr. Hill, a previous CAP awardee, will study the role of Interleukin-8 in alcoholic liver disease. Dr. McNamara, a Division Director in the School of Pharmacy, will evaluate drug transfer in breast milk. Dr. Young, Chairman of Surgery, will evaluate growth factors following head injury. Dr. Knapp, Director of the Wenner-Gren Research Laboratory will study the effect of lower body negative pressure on cardiovascular function and its implications for space flight. Dr. Shedlofsky from Internal Medicine and Toxicology will evaluate the effect of inflammatory mediators on hepatic drug metabolism. Dr. Kelly from Behavioral Sciences will evaluate the influence of age and sex on the effects of certain drugs. Dr. McClain, Director of our GCRC, will evaluate regulation of tumor necrosis factor production and its role in liver injury. In summary, the University of Kentucky GCRC has made major contributions to clinical research during the past five years. Our new unit, improved staffing, and an increasing number of unique and complex protocols will facilitate our continued contribution to clinical research over the next five years.
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