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Simplifying the Landscape of NIH Clinical Trial Funding Opportunities
As part of evolving efforts to simplify the landscape of Notices of Funding Opportunity (NOFOs), NIH is developing a suite of broad clinical trial NOFOs organized around different types of clinical trials rather than specific diseases or scientific topics. These opportunities can support research across multiple areas while promoting a shared approach to clinical trial funding among the NIH Institutes, Centers, and Offices (ICOs). The ultimate goal is to make it easier for investigators to identify the most appropriate funding opportunity for their research while creating a more consistent framework for supporting similar types of studies across NIH.
Why a New Approach?
Historically, many ICOs developed their own clinical trial NOFOs or participated in co-funding opportunities tailored to their distinct scientific areas. Although this approach enabled targeted announcements, it also created a complex landscape for investigators, who often encountered different application instructions, review criteria, and ICO-specific processes and requirements in the NOFOs.
What Is Changing?
To create a more coordinated framework for clinical trials, ICOs are working together to develop a suite of broad NOFOs organized around the type of clinical trial rather than specific scientific content areas. As broad announcements applicable to multiple ICOs, the suite will complement the currently existing NIH Parent Announcements. The suite is designed to span a range of activities—from feasibility testing through implementation research—while recognizing that different trial types require different methodological approaches, levels of preliminary evidence, and study designs. The new suite provides multiple opportunities for investigators to identify the NOFO that most closely aligns with their research. To avoid gaps, there is some intentional overlap in the types of clinical trials each NOFO will support.
The following table describes the suite of clinical trial NOFOs. Each clinical trial type is currently forecasted to help researchers prepare while the potential NOFOs are under review; however, forecasts are informational only.
| Clinical Trial Type | Activity Code | Primary Objective |
|---|---|---|
| Feasibility Trials | R34 | Supports feasibility clinical trials that prepare for future larger-scale clinical trials. Feasibility clinical trials can inform the design and conduct of future Phase II-IV, Stage II-V, efficacy, effectiveness, pragmatic, dissemination, or implementation trials. |
| Early to Definitive Trials | R61/R33 | Supports clinical trials early in the development pipeline, from early phase clinical trials (e.g., first in human, discovery, safety, dosing, validation, Phase I, Stage I) to early definitive trials (e.g., Phase II, Stage II, efficacy). |
| Multi-Site Trials | UG3/UH3 | Supports multi-site clinical trials of efficacy, effectiveness, or hybrid effectiveness/implementation trials and large decentralized or “virtual” mHealth trials (e.g., Phase II or III, Stage III or IV). |
| Pragmatic & Implementation Trials | UG3/UH3 | Supports large, pragmatic trials that test the effectiveness of evidence-based interventions and/or implementation strategies in real-world health care or public health settings (e.g., Phase III or IV, Stage IV or V). |
| Network Trials | UG3/UH3 | Supports all types of clinical trials that will use the infrastructure of NIH-funded clinical trial networks. |
Scientific Priorities Remain Central
Importantly, scientific priorities remain central to NIH programmatic planning and funding decisions for clinical trials. NIH continues to communicate scientific interests through ICO profile pages, strategic plans, Highlighted Topics, and other programmatic resources. In addition to the suite of broad NOFOs, applicants may also still see targeted clinical trial funding opportunities from individual ICOs based on specific programmatic needs.
Benefits of the New Approach
Among the benefits of developing a suite of broad clinical trial NOFOs is that it will:
- Make it easier for investigators to identify the right NOFO for their goals and focus on designing high-quality clinical trials.
- Provide consistent application instructions for similar trial types.
- Enhance the methodological rigor of clinical trial applications.
- Facilitate coordination and co-funding across ICOs.
- Improve planning and tracking of clinical trial activities within NIH.
More to Come
The clinical trial NOFO suite is being implemented in phases. NIH will continue to provide additional information and resources on these and any other related funding opportunities as they are issued. We encourage researchers to contact appropriate ICO staff identified on any funding opportunity that may be published to discuss finding the best fit for their science (see also this NIH Extramural Nexus article). Please check back here for updates on any of these upcoming funding opportunities.
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