NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)
HHS-NIH11
Status:
Active
January 15, 2021
Posted:
Deadline:
January 7, 2024
Funding
Program:
Award Floor:
Ceiling:
Match Required?
No
Eligibility
All
States:
Entity Types:
State governments, County governments, City or township governments, Special district governments, Independent school districts, Public & State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations, Nonprofits (with 501(c)(3) status), Nonprofits (without 501(c)(3) status)
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. The proposed trial can be single or multisite. Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period. Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award. If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA which utilizes an R61/R33 phased approach.