NIAID is offering cooperative agreement funding to support investigator-initiated clinical trials that require enhanced oversight, with milestone-driven execution and, optionally, included mechanistic studies. Trials can be funded for up to 5 years, with possible extensions to 6–7 years, and each application may propose only one clinical trial. This opportunity is intended for rigorous clinical research aimed at improving understanding of human diseases and advancing therapies.

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.