Opportunity

Simpler Grants.gov #PAR-27-064

NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Buyer

National Institutes of Health

Posted

June 16, 2026

Respond By

July 05, 2029

Identifier

PAR-27-064

NAICS

541715

This opportunity is a funding announcement from the National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), for clinical trial implementation: - Government Buyer: - National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID) - Purpose: - Soliciting applications for investigator-initiated, milestone-driven clinical trials requiring enhanced oversight - Emphasis on including mechanistic studies within clinical trials to advance understanding of human diseases and future therapies - Application Details: - Only one clinical trial may be proposed per application - Open to a wide range of organizations: nonprofits, government entities, educational institutions, businesses, and foreign organizations - Period of Performance: - Support for up to 5 years, with possible extensions to 6 or 7 years for extended trials - No specific OEMs, vendors, or product procurements are involved, as this is a research funding opportunity, not a product or service acquisition - Unique Requirements: - Clinical trials must be milestone-driven and include enhanced oversight - Mechanistic studies are encouraged within the clinical trial framework

Description

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that require enhanced oversight and may include mechanistic studies. The mechanistic work in clinical trials aims to promote understanding of human diseases and development of future therapeutic modalities. Support is available for clinical trials up to 5 years, with options for extended clinical trials of 6 or 7 years. Only one clinical trial may be proposed per application, and applications will be peer-reviewed with only meritorious applications considered.

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