NIAID Clinical Trial Implementation Cooperative Agreement (U01)

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Purpose. The purpose of this Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) is to invite applications that propose implementation of investigator-initiated high-risk clinical trials. The trials must be hypothesis-driven, related to the research mission of the NIAID and considered a high priority by the Institute. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/.) Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation (U01) Cooperative Agreement application. Mechanism of Support. This FOA will utilize the NIH Cooperative Agreement (U01) mechanism, and will run in parallel with two related FOAs, PAR-10-184 and PAR-10-185, that invite applications that propose planning of investigator-initiated clinical trials and implementation of non-high-risk investigator-initiated clinical trials, respectively. Pre-approval by the NIAID is required for submission of an application under all three FOAs. Funds Available and Anticipated Number of Awards. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received.

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