Funding Organization: National Institutes of Health (NIH)
Total Funding Amount: Not specified
Duration: 6 or 7 years
Primary Objective: To support investigator-initiated clinical trials that are hypothesis-driven and aligned with NIH's research mission.
Key Stakeholders: NIH, participating institutes, and clinical trial participants.
Funding Source: Federal government.
Significance: Addresses critical health-related questions through extended clinical trials.
Grant Frequency: Recurring.
Higher Education Institutions
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits (with and without 501(c)(3) status)
For-Profit Organizations
Small Businesses
Local, State, County, and City Governments
Indian/Native American Tribal Governments (both recognized and unrecognized)
Federal Government Agencies
U.S. Territories
Other (e.g., Independent School Districts, Public Housing Authorities, Faith-based Organizations, Foreign Institutions)
Organizations must complete registrations with SAM, eRA Commons, and Grants.gov prior to application submission.
All PDs/PIs must have an eRA Commons account.
Clinical trials across all phases.
Must address scientifically important questions with potential to change clinical practice.
Milestone-driven projects with clear objectives and contingency plans for delays.
Inclusion of mechanistic studies as part of the application.
Applicants must demonstrate the ability to conduct clinical trials and meet milestones.
Plans for implementing Good Clinical Practices (GCP) must be included.
Application budgets are not limited but must reflect actual project needs.
Incremental funding will be provided over the project period.
Open Date: April 13, 2023
Application Due Dates: Various dates from May 15, 2023, to January 13, 2026.
Expiration Date: January 14, 2026.
Must adhere to NIH Grants Policy Statement and federal regulations.
Clinical trials must comply with FDA regulations if applicable.
Applications must be submitted electronically via Grants.gov.
Compliance with SF424 (R&R) Application Guide is mandatory.