Clinical Trial Planning: Therapeutic/Indication Pairing Strategies (U34) (Clinical Trials Not Allowed)

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The U34 award will support clinical trial planning. This includes collection of feasibility data and complete planning, design, and preparation of the documentation necessary for implementation of Phase I and/or Phase II clinical trials for a new therapeutic use. The clinical trial that is being planned must aim to repurpose existing drugs or biologics (therapeutics) that have already completed at least a Phase l trial for a different indication by the time a clinical trial planning 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.

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