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Editorial · CASRAI · Clinical research and clinical trials

NIH Plans Broad Clinical Trial NOFOs Organised by Trial Type

On 10 November 2026 NIH said it is developing broad clinical trial NOFOs organised by trial type, not disease. The plan is phased, and forecasts are informational only.

Published 13 Nov 2026· 3 minute read

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On 10 November 2026, NIH published an item in its Extramural Nexus titled “Simplifying the Landscape of NIH Clinical Trial Funding Opportunities.” It says NIH is developing a suite of broad clinical trial Notices of Funding Opportunity (NOFOs) organised around types of clinical trial, rather than around specific diseases or scientific topics. NIH presents this as part of its wider effort to simplify the NOFO landscape. This is a plan under development, not a final policy, and the item states that the forecasts it describes are informational only.

What NIH has said

  • The broad NOFOs are intended to complement NIH’s existing Parent Announcements and are being implemented in phases.
  • Each trial type is forecast so that researchers can prepare, but the forecasts are informational only. The item gives no opening or due dates, and says NIH will share more information as opportunities are issued.
  • Individual Institutes, Centers and Offices (ICOs) may still issue targeted clinical trial funding opportunities, and NIH continues to signal scientific interests through ICO profile pages, strategic plans and Highlighted Topics.
  • Stated aims include making it easier for investigators to identify the right NOFO, consistent application instructions for similar trial types, stronger methodological rigour, easier co-funding across ICOs, and better planning and tracking of clinical trial activity.

The planned trial types

The item lists five trial types with their activity codes. The objectives below are summarised from NIH’s table.

Trial type Activity code(s) Summary of objective
Feasibility trials R34 Prepare for larger later trials, informing the design and conduct of Phase II–IV, efficacy, effectiveness, pragmatic, dissemination or implementation trials.
Early to definitive trials R61/R33 Early-pipeline work, from first-in-human, safety and dosing studies (Phase I, Stage I) to early definitive trials (Phase II, Stage II, efficacy).
Multi-site trials UG3/UH3 Multi-site efficacy, effectiveness or hybrid effectiveness/implementation trials, and large decentralised or “virtual” mHealth trials (Phase II or III, Stage III or IV).
Pragmatic and implementation trials UG3/UH3 Large pragmatic trials of evidence-based interventions and/or implementation strategies in real-world health care or public health settings (Phase III or IV, Stage IV or V).
Network trials UG3/UH3 All types of clinical trials that use the infrastructure of NIH-funded clinical trial networks.

What it may mean for researchers and research offices

The following is editorial interpretation, not NIH guidance. Because the organising principle is trial design, investigators may find it more useful to choose a NOFO by the type of trial they are running than by topic area. Research offices that support clinical trial applications may want to watch the forecasts, since the activity codes involved (for example R61/R33 and UG3/UH3 phased awards) carry milestone or transition structures that affect budgeting and internal review timelines. Nothing in the item changes current requirements, and applicants should keep following the instructions in the specific NOFO they apply to, including its clinical trial designation. For related changes, see our guide to NIH funding opportunity changes in FY2026.

What is not yet known

The item does not give release dates for the individual NOFOs, and it does not cite an NIH Guide notice number. We searched for a related NIH Guide notice and did not find one, so none is cited here. Readers should check the NIH Guide for Grants and Contracts and the Extramural Nexus for updates as opportunities are issued.

Sources

Referenced across the research world

University of Cambridge logoColumbia University logoCrossref logoUniversity of Edinburgh logoHarvard University logoUniversity of Oxford logoPrinceton University logoStanford School of Medicine logoUniversity College London logoORCID logoUniversity of Cambridge logoColumbia University logoCrossref logoUniversity of Edinburgh logoHarvard University logoUniversity of Oxford logoPrinceton University logoStanford School of Medicine logoUniversity College London logoORCID logo
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