National Institutes of Health

Description

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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

NIH OER Webmaster <br/>FBOWebmaster@OD.NIH.GOV
FBOWebmaster@OD.NIH.GOV