GENERAL CLINICAL RESEARCH CENTER

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EXCEED THE SPACE PROVIDED. The General Clinical Research Center (GCRC) at Harbor-UCLA Medical Center is now in its 31st year of operation. This proposal requests continued support for five years (12/1/01 to 22/30/06) for an inpatient unit (1000 days), outpatient facilities (5,500 visits), a Perinatal Clinical Research Center (PCRC) at Harbor-UCLA and a satellite PCRC at King-Drew Medical Center. The GCRC satellite at Cedars is growing with a 64% increase in number of research protocols with new activities encompassing perinatal research as well as genotyping (630,833 genotypes) and cell line development (2,614 cell lines) in the Genotyping-Phenotyping Core. The current applicationcontains 100 protocols from Harbor-UCLA and 72 protocols from Cedars-Sinai Medical Center. The past five years have witnessed an increased collaboration between the GCRCs at Harbor and Cedars as exemplified by a twofold increase in the number of collaborating investigators and shared protocols (16 protocols). Much of this collaborative activity is encompassed in perinatal research as well as genotyping and cell line development in the recently funded genotyping-phenotyping core at Cedars-Sinai. The GCRCs at both institutions are the focus of clinical research training from the mentored clinical research trainee at the junior faculty level to high school students through MH funded and other outreach programs. Our research focus has been on androgen therapy and male contraceptive development; pharmacogenetics and psychobiology of ethnicity; mechanisms of infection by mycoses; exercise trainingand frailty in older men and men with chronic diseases; maternal fetal osmoregulation, and the genetic basis of diseases including hypertension and chronic inflammatory bowel disease. We continue to support high volume outpatient studies,( e.g., Women's Health Initiative, identification of diabetic genes), high intensity inpatient studies (e.g., metabolic and multiple sampling studies), perinatal research, and genetics of common diseases (diabetes, atherosclerosis, hypertension, osteoporosis). To meet the needs of our investigators and the changing clinical research focus, we propose: 1) to further expand our outpatient research capability (new outpatient facilities at Harbor, increased outpatients visits at both centers); 2) to add data and safety monitoring advisors/monitors to safeguard the safety of research subjects; 3) to encourage collaboration between the three centers by establishing a PCRC at Cedars; and 4) to increase use of the cell-line and genotype/phenotype core by both centers.