NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required) - PAR-27-065
Funder
National Institutes of Health
LOI Required
No
Application Deadline
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Maximum Project Duration
5 years
Research Focus Areas
New
Clinical
Neurobiology/Neuroscience
Prevention
Treatment Development
Description
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage grant applications for investigator-initiated clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS) that are intended to develop interventions to prevent or improve outcomes of neurological disorders. Applications addressing questions within the mission and research interests of the NINDS may include studies of drugs, biologics, or devices, as well as surgical, behavioral, diet-based, or other types of interventions meant to prevent or treat disorders within the NINDS mission. This NOFO uses the UG3/UH3 phased award mechanism. Projects that demonstrate satisfactory progress during the UG3 phase are eligible to transition to the UH3 phase.
Scope of the Program
This NOFO provides the primary opportunity for the submission of applications for early and middle phase exploratory trials, confirmatory/pivotal clinical trials, and comparative effectiveness clinical trials aimed at testing promising interventions for neurological disorders. Pragmatic trials performed in large numbers of participants with minimal alteration from clinical practice and low per-patient costs are also encouraged.
For medical devices, early feasibility and traditional feasibility study designs may include single-arm case series, within subject designs, device comparisons, comparisons to historic controls, comparisons to performance controls, or adaptive/Bayesian designs.