NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required)

The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This FOA will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.