NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
Supports investigator-initiated early-phase Phase I clinical trials of therapeutics and/or diagnostics for heart, lung, blood, and sleep disorders, including required pre-trial preparatory activities directly tied to the intervention.
⚑ Clinical trial required. · R61/R33 phased, milestone-driven mechanism. · R61 phase supports only final-stage pre-trial activities directly related to the therapeutic/diagnostic intervention (e.g. stability, shipping, site training).
Unit fits — one characterization, each unit's own rules
| IPPRA | 58 good | peripheral portfolio topic: public_health; social/behavioral work is minor; funds evaluation research; biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped) |
| Physical Sciences & Engineering (demo) | 25 weak | technical depth: minor; funds evaluation research (capped) |
| Tom Love Innovation Hub | 15 none | deep-tech content; no commercialization signal |
Description
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 NOFO 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.
Eligibility
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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <grantsinfo@nih.gov>
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