Clinical Studies Core

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The Clinical Studies Core will conduct studies in humans on promising vaccines and therapeutics that emerge from the laboratories of NERCE or from the biodefense related work of other scientists in our region. The Core will collaborate with other investigators in protocol design and will provide a cadre of trained and experienced clinical investigators and support personnel to conduct the studies. Data collection, quality control, and statistical analysis will also be provided. The core will also collect, prepare, preserve, store, and retrieve clinical samples, including specimens of blood, mucosal secretions, and tissues. The Core will maintain a program to recruit a steady flow of subjects with a variety of characteristics, with emphasis on inclusion of women and minorities in the studies. Training of investigators and visiting workers in proper conduct of clinical studies will be offered. The Clinical studies will be conducted primarily in an ambulatory site at Brigham and Women's Hospital which consists of 10 fully equipped examination rooms, and auxiliary space dedicated exclusively to clinical studies. The site will be able to accommodate 150 subjects annually with a total of 1500 visits per year. In patient studies can be performed in the 11 bed GCRC unit at Brigham and Women's Hospital, which can accommodate at least 200 bed days for our studies. It is anticipated that the majority of clinical studies will be of the early "phase I or ir' types, and that all six of the proposed research projects will utilize the Clinical Studies Core. Intensive efforts will be undertaken to make investigators aware of the existence of and services provided by the Core, and to encourage use of its capabilities by investigators both at NERCE and elsewhere in the region.