The National Institutes of Health (NIH) is developing a unified approach to clinical trial funding, organizing opportunities by trial design rather than specific diseases. This shift intends to streamline submission guidelines so researchers face identical requirements across all trial categories.
Previously, individual NIH institutes crafted separate Notices of Funding Opportunity (NOFOs) with distinct guidelines and evaluation standards. Under the revised framework, five standardized NOFOs will cover key trial types: feasibility studies, early-to-definitive trials, multisite investigations, pragmatic trials, and network-based research. A feasibility study for cardiovascular research, for instance, would now follow the same application process as one focused on neurological conditions.
Funding Overhaul for Clinical Trials
Instead of relying on NOFOs to highlight research priorities, institutes will now emphasize their focus areas through updated institute profiles, strategic plans, and designated “Highlighted Topics.” This restructuring follows recent NIH initiatives, including the consolidation of career development awards, reclassification of human experimental studies, and a reduction in active NOFOs—from over 800 at the beginning of 2025 to under 500 by year’s end.
The new trial-specific NOFOs will operate alongside existing broad grant programs, such as the R01 research project grants and R21 exploratory/developmental awards. Researchers will retain the option to submit proposals through these traditional channels rather than the specialized trial NOFOs.
During a May presentation at the Society for Clinical Trials meeting, an official from the National Heart, Lung, and Blood Institute (NHLBI) revealed NIH’s potential timeline for releasing the updated NOFOs, likely between late 2026 and early 2027.
Opposition and Unanswered Questions
Some researchers fear the reforms could weaken financial support for neglected research fields. Elizabeth Ginexi, a former NIH program officer, cautioned that eliminating targeted NOFOs removes explicit funding signals for underrepresented scientific areas. In a Substack post, she stated: “When you eliminate targeted NOFOs, you eliminate the funding signal for exactly those areas of science that would otherwise be overlooked.”
Two NIH institutes have already adopted similar trial-type funding models. The National Center for Complementary and Integrative Health (NCCIH) transitioned most of its trials to this system in 2017, while NHLBI supported 218 investigator-led trials through comparable NOFOs between fiscal years 2017 and 2024.
