This funding opportunity supports investigator-initiated Phase I clinical trials for diagnostic and therapeutic interventions addressing heart, lung, blood, and sleep disorders in adults and children. It provides resources for clinical trial start-up, implementation, and final preclinical activities necessary for trial readiness. The award uses a bi-phasic, milestone-driven mechanism with an initial R61 phase focused on pre-trial activities such as stability testing, shipping studies, and site training. Trials may be single or multisite.
Eligible applicants include Native American tribal governments, nonprofits, county and state governments, institutions of higher education, for-profit organizations other than small businesses, small businesses, and various government entities. See full eligibility details for specifics.
