Key Dates

PAR-18-422 - NINDS Efficacy Clinical Trials (U01 Clinical Trial Required)

National Institute of Neurological Disorders and Stroke (NINDS)

This notice informs the research community that the National Institute of Neurological Disorders and Stroke (NINDS) intends to reissue Funding Opportunity Announcement (FOA) PAR-18-422 "NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required)".

The FOA is expected to be published in May 2021 with an expected application due date in June 2021.

This FOA will no longer utilize the U01 activity code. Instead, it will be reissued using the UG3/UH3 grant mechanism. This Notice is being published now to inform prospective applicants in advance of this modification and to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.  Details of the planned FOA are provided below.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated efficacy clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may include studies of drugs, biologics, and devices, as well as behavioral or other types of interventions meant to prevent or treat a neurological disorder. This FOA uses the UG3/UH3 mechanism. Only projects that provide satisfactory progress in the UG3 phase may move to the UH3 phase.

NIH defines a clinical trial as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." Note the following:

• For purposes of this FOA, the proposed study should be intended to prevent or treat a disorder of the nervous system within the NINDS mission.
• An application involving a clinical experiment that is not directly intended to develop a preventative or therapeutic intervention is not suitable for this FOA. This would include, for instance, an experiment where the objective is to elucidate the pathogenesis of the disease or to identify potential therapeutic targets for future trials.
• Under this FOA NINDS will accept renewal applications to request additional years or funds to complete the original scientific aims of the efficacy clinical trial.
• This FOA will only support Phase 3 or Phase 4 clinical trials conducted to provide a definitive answer regarding the safety and efficacy of an intervention or to compare the effectiveness of two or more interventions. The proposed research must address a scientifically important question, provide valuable information to the existing knowledge base, and have public health relevance. The trial design should ensure that high quality, complete data regarding the primary outcome will be collected in the most efficient manner in terms of time, resources, and burden to subjects. Secondary outcomes should be included only when they are anticipated to provide important supportive or explanatory data. The necessity of each secondary endpoint must be justified in light of cost and burden. Pragmatic trials requiring minimal data collection and low cost per subject are encouraged.
• This FOA also may be used for the submission of an adaptive trial utilizing a seamless Phase 2/3 transition where data from subjects in Phase 2 are included in the analysis of Phase 3.

Applications are not being solicited at this time. 

Please direct all inquiries to:

Jeremy Brown, MD

National Institute of Neurological Disorders and Stroke (NINDS)

301-496-9135

Jeremy.brown@nih.gov