FILE: NIH’s James H. Shannon Building (Building 1) in Bethesda, Maryland, February 3, 2010. Photo: Lydia Polimeni/National Institutes of Health, public domain, via Wikimedia Commons; cropped.
The National Institutes of Health is developing a new set of clinical-trial funding announcements organized by the type of study rather than by a particular disease or scientific topic, a change intended to make applications more consistent across the agency.
NIH outlined the approach in a November 10 update. The planned opportunities range from feasibility studies to large trials conducted in real-world health care settings, with several NIH institutes, centers and offices working on a shared framework.
The announcements are still under review. NIH says the published forecasts are informational only. The update does not announce new grant awards, a funding total or a single opening date for all the opportunities.
Five Types of Trials
The planned suite has five categories. Feasibility trials would use the R34 activity code to support preliminary studies that help prepare for larger trials. Early-to-definitive trials would use the R61/R33 structure and cover work from early human testing through early studies of whether an intervention works.
Multi-site trials would use UG3/UH3 awards for studies involving multiple sites, including large decentralized or virtual mobile-health trials. A separate UG3/UH3 category would cover pragmatic and implementation trials that test established interventions or implementation strategies in real-world settings.
The fifth category, also using UG3/UH3, would support trials that use the infrastructure of NIH-funded clinical-trial networks.
NIH said some overlap between categories is deliberate, intended to help avoid gaps between the kinds of studies the announcements can support.
Scientific Priorities Would Remain
The agency said its existing approach can leave researchers facing different instructions, review criteria and institute-specific requirements for similar trial designs. The broader announcements are intended to make it easier to find an appropriate opportunity and support coordination and co-funding across NIH.
That does not mean disease-specific priorities are disappearing. NIH said scientific priorities will remain central to funding decisions, and individual institutes may still issue targeted trial opportunities based on their own program needs.
The new suite would complement existing NIH parent announcements rather than replace them outright. It is being implemented in phases, with more information to follow as individual opportunities are issued.
Researchers should distinguish the forecasts from published funding announcements. NIH advises investigators to contact the appropriate staff listed in a published opportunity to discuss whether their science is a good fit.
Source: NIH’s clinical-trial funding update.
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