UNIVERSITY OF SOUTHERN CALIFORNIA CLINICAL TRIALS UNIT

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DESCRIPTION (provided by applicant): The Clinical Trials Unit (CTU) at DSC was the number one performing Unit for relative cost per weighted accrual for the past 5 years, number two for % enrollment of minorities for the past three years and number two for overall accrual during the past 12 months (through 6/05). There are currently 103 study subjects on ACTG studies at USC. There are 63% Latinos and 27% women of the nearly 3000 patients attending the Rand Schrader Clinic, site of the USC CTU and CRS, which closely replicates our accrual to aACTG studies. The Site Evaluation Subcommittee (9/2004) highly commended the Unit on its exceptional performance for relative cost per weighted accrual, monitoring-source documentation, monitoring-endpoint determination, enrollment of Hispanics, laboratory shipping score, and timeliness of protocol registrations packets. As Dr. Sattler took over as Principal Investigator on 7/1/05, the CTU was reorganized. Several former ACTG, now mid-career investigators were recruited as Key Personnel, and several nationally renowned USC investigators with expertise in areas of high priority for Network research were included as Consultants and Collaborators. The primary goal of these changes was to augment the scientific contributions from the USC CTU with the expectation that the breadth and expertise of these investigators will provide a major impact in helping to shape the future CTN research agenda. This group of distinguished investigators includes 8 women and 5 faculty representing ethnic or racial minorities with expertise in clinical virology; immunology; mycology; tuberculosis; endocrinology/metabolism; hepatology; cardiology; adolescent and child care, women's health; and pharmacokinetics, pharmacodynamics and pharmacogenomics. Moreover, the USC CTU will continue its long-time commitment to the development of junior investigators, as Key Personnel will mentor 4 junior faculty or fellow-instructor trainees (2 women and 2 minority men) as CRS investigators in learning the principles of HIV clinical and translational research. Finally, this investigative group will allow the USC CTU/CRS to continue to perform at the same high level as in recent years in achieving the Network research agenda. They will also participate in ACTG group-wide meetings and contribute concept proposals for novel new treatment and prevention strategies to be tested in resource limited settings (e.g. East LA) that will often be applicable for the care of patients in developing countries. ADMINISTRATIVE COMPONENT: