An essential element of a Regional Center of Excellence (RCE) for Biodefense and Emerging Infectious Disease Research proposal is the capacity to coordinate and conduct phase I and il clinical tirals as well as to conduct relevant popluation based epidemiologic studies and diagnostic validation studies. The UCLA Center for Vaccine Research has the expertise, experience, staffing, resources and facilities to conduct such clinical evaluations that will contribute to the RCE's mission for translational research.
The specific aims for our core proposal include: 1) collaborate with RCE investigators to evaluate pre-clinical evaluations and develop clinical research plans, 2) develop and write protocols for phase I and phase II clinical evaiuatjons and epidemiologic studies, 3) develop relevant consent forms, regulatory documents, data collection instruments and procedures, 4) identify appropriate study populations, 5) conduct clinical trials, epidemiologic studies, and validation studies for new diagnostics, and 6) perform data collection and data analyses and prepare clinical reports and manuscripts.
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