The Clinical Research Program and the Treatment Research Operations Program of DAIDS conduct clinical trials to evaluate potentially effective therapeutic interventions against HIV infection and its sequelae. These trials are conducted through an academic-based consortium of medical institutions called the AIDS Clinical Trials Group (ACTG), as well as a community-based consortium called the Community Programs for Clinical Research on AIDS (CPCRA). The purpose of this contract will be to provide DAIDS with a third clinical trials mechanism, separate and distinct from both the ACTG and the CPCRA, which will enable DAIDS to rapidly address critical questions about therapeutic agents or innovative intervention approaches and to evaluate potentially effective therapies, which may fall outside the immediate priorities of the existing consortia. This contract specifically will not replicate the structure, functions, or research conducted through the ACTG and CPCRA systems; rather, it is expected to complement those important research activities. The contractor will provide personnel, materials, equipment and facilities to accomplish the following tasks: a. Provision of medical and statistical expertise for study design and interpretation b. Protocol development and review c. Provision of clinical trial sites and laboratory services d. Provision of an investigational drug repository and distribution service e. Site monitoring, site registration, preparation of INDs and other tasks required for regulatory compliance f. Provision of a biospecimen repository g. Implementation of clinical trials h. Data management and analysis services
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