NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)

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. The proposed trial can be single or multisite. Applicants applying for funding under this NOFO 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 NOFO which utilizes an R61/R33 phased approach.

Official source

Eligible beneficiaries

• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• Independent school districts
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Native American tribal organizations (other than Federally recognized tribal governments)
• Native American tribal governments (Federally recognized)
• State governments
• Public and State controlled institutions of higher education
• Small businesses
• City or township governments
• County governments
• Special district governments
• For profit organizations other than small businesses
• Private institutions of higher education
• Public housing authorities/Indian housing authorities