Clinic Testing Therapeutic/Indication Pairing Strategies (U01 Clinical Trial Required)

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This Funding Opportunity Announcement (FOA) invites applications for support of clinical studies to repurpose existing drugs or biologics (therapeutics) that have already completed at least a Phase l trial for a different indication by the time an award is made. The hypothesis for proposed studies must be developed using innovative processes to identify the therapeutic/indication pair. Examples include independent crowdsourcing strategies (e.g., http://www.ncats.nih.gov/ntu/therapeutics/current, http://openinnovation.astrazeneca.com/, or any website that lists experimental drugs or biologics), or computational algorithms. Projects should be supported by scientific evidence that modulation of a therapeutic target will have a positive impact on the disease/condition. The U01 award may be used for Phase I and/or Phase II clinical trials for a new therapeutic use to establish substantial evidence of efficacy and to establish evidence of safety for the new use.

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