This funding opportunity supports clinical projects that address critical needs for clinical trial readiness in rare diseases. It funds development and testing of biomarkers, clinical outcome assessments, and defining disease presentation to facilitate efficient movement of therapeutics or diagnostics toward clinical trials, increasing their likelihood of success. Clinical trials themselves are not allowed under this R21 mechanism.
Eligible applicants include a wide range of U.S. entities such as government bodies, higher education institutions, nonprofits, small businesses, tribal organizations, and certain minority-serving institutions. Foreign organizations and foreign components are not eligible.
