Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)

The National Institutes of Health will issue a Notice of Funding Opportunity (NOFO) inviting applications for early‑to‑definitive clinical trials using the NIH R61/R33 bi‑phasic award mechanism. The R61 phase funds trial planning and design; the R33 phase funds execution of the clinical trial, with a total project period of up to seven years. Eligible applicants include a broad range of nonprofit, governmental, tribal, and for‑profit entities. The initiative targets trials of drugs, devices, biologics, procedures, behavioral, social, economic, health‑services, or other biomedical/non‑pharmacological interventions that align with NIH Institutes, Centers, and Offices missions. No solicitation is open yet; this forecast provides lead time for collaboration development. • Funding mechanism: R61 (planning) → R33 (clinical trial) bi‑phasic, milestone‑driven award. • Maximum project duration: 7 years. • Eligible applicants: nonprofits (501(c)(3) and others), state/local governments, tribal entities, small businesses, higher‑education institutions, and foreign institutions. • Target research areas: any clinical trial (drug, device, biologic, behavioral, etc.) that fits NIH mission. • Anticipated timeline: posting 09/29/2026, synopsis posting 05/31/2027, application response 07/31/2027, award 04/30/2028, project start 04/30/2028. • Contact: NIA Scientific Program Contact (email provided).