NIAID Clinical Trial Implementation Cooperative Agreement

The National Institute of Allergy and Infectious Diseases (NIAID), under the National Institutes of Health and the Department of Health and Human Services, is soliciting applications for the NIAID Clinical Trial Implementation Cooperative Agreement under solicitation number PAR-27-064. This program is designed to support investigator-initiated, milestone-driven, high-risk clinical trials and associated mechanistic studies, bridging the gap between basic and clinical research. The funding covers the entire lifecycle of the trial, including conduct, completion, and analysis, as well as essential operational activities such as personnel training, subject recruitment, data management, quality control, laboratory work, regulatory activities, and site monitoring. This opportunity is classified as a U01 Clinical Trial Required agreement and is a reissue of PAR-24-100. The solicitation was posted on June 27, 2025, with the first application date set for September 5, 2026, and an expiration date of July 6, 2029. The program operates under the authority of the Public Health Service Act and relevant federal regulations to ensure rigorous oversight of the clinical trials. Interested parties can coordinate with the point of contact, Cynthia de la Fuente, Ph.D., at the National Institute of Allergy and Infectious Diseases.