The National Institutes of Health (NIH), in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute on Aging (NIA), has reissued a Funding Opportunity Announcement (FOA) for investigator-initiated extended clinical trials. The FOA, identified as PAR-23-084, supports applications for clinical trials requiring an extended project period of six to seven years. These trials can be of any phase but must be hypothesis-driven and align with the mission of one of the participating NIH institutes. This FOA is intended for trials that require a long-term follow-up period due to the nature of the disease or intervention being studied. Clinical trial planning activities must be completed before application submission, as the grant supports full implementation of the proposed trial.

The trials supported under this FOA must address significant research questions with the potential to influence clinical practice or contribute to scientific knowledge. The rationale for the trial and the need for an extended project period should be well justified, including factors like the complexity of the disease under study, recruitment challenges, or the diversity of study sites. Only one clinical trial per application is allowed, and observational studies, pilot studies, or feasibility studies will not be considered.

The funding instrument is a grant, with no specific limits on the application budget, which should reflect the actual needs of the trial. The project period is limited to six or seven years, depending on the trial's scope. Applicants are expected to outline detailed milestones for the trial, including key stages such as recruitment, data collection, analysis, and reporting. NIH staff will closely monitor progress against these milestones, and failure to meet recruitment or other key targets may result in the termination of the grant.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and governmental bodies. Foreign institutions and foreign components of U.S. organizations are also eligible to apply. The FOA encourages early consultation with NIH staff, at least 10 weeks prior to the submission deadline, to ensure the proposed clinical trial aligns with NIH priorities and meets all regulatory requirements. Applications must be submitted electronically, and compliance with all submission instructions is mandatory.

Key submission dates occur annually through 2026, with upcoming deadlines on January 16, 2024, and May 13, 2024. Scientific merit review will take place shortly after each deadline, and applicants are advised to submit early to allow for error corrections during the submission process. No late submissions will be accepted. Applications are evaluated based on criteria such as significance, innovation, approach, investigator qualifications, and the research environment.

The FOA emphasizes the importance of a comprehensive data management and sharing plan and requires inclusion of a detailed clinical protocol and timeline with specific milestones. Post-award monitoring will ensure adherence to Good Clinical Practices (GCP), and trials involving FDA-regulated interventions must meet relevant regulatory requirements.

This initiative aims to support long-term clinical trials addressing critical health challenges in areas relevant to NIAID and NIA, such as infectious diseases, immunology, aging, and dementia. Investigators are encouraged to contact program staff to ensure their proposed trial fits the scope of this extended project period mechanism.