NOT-NS-21-054: Notice of Intent to Publish the Reissuance of PAR-18-420, NINDS Exploratory Clinical Trials (U01

Notice of Intent to Publish the Reissuance of PAR-18-420, NINDS Exploratory Clinical Trials (U01 - Clinical Trial Required)

Notice Number:

NOT-NS-21-054

Key Dates

Release Date:

April 05, 2021

Estimated Publication Date of Funding Opportunity Announcement:

May 04, 2021

First Estimated Application Due Date:

June 05, 2021

Earliest Estimated Award Date:

February 01, 2022

Earliest Estimated Start Date:

April 01, 2022

Related Announcements

PAR-18-420 - NINDS Exploratory Clinical Trials (U01 Clinical Trial Required)

Issued by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

This notice informs the research community that the National Institute of Neurological Disorders and Stroke (NINDS) intends to reissue Funding Opportunity Announcement (FOA) PAR-18-420 "NINDS Exploratory Clinical Trials (U01 Clinical Trial Required)".

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

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

This FOA will continue to utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated exploratory 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 Phase 1 and 2 studies of drugs and biologics, feasibility studies of devices, and early studies of surgical, behavioral or rehabilitation therapies. All exploratory trials must contribute to the justification for, and provide some of the data required to inform a future trial to establish efficacy (such as a Phase 3, Phase 4 or Pivotal trial).

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:

A wide range of trials at different stages of development are supported under this FOA, including (but not limited to) first-in-human (as defined by the Food and Drug Administration), Phase 1 and 2 single-site studies, Phase 2b multicenter studies, and single- or multi-site feasibility studies of devices. Applications should aim to generate data that inform further clinical development of the proposed intervention. The earliest studies should be designed to provide important initial information regarding the intervention (e.g., safety, tolerability, dosing). When appropriate, later-stage studies should include randomization and blinding and should yield data that allow a clear go/no-go decision regarding whether the intervention should proceed to an efficacy trial.

For purposes of this FOA, the proposed study should be intended to clinically develop the interventions 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 identify potential therapeutic targets for future exploratory trials.
NINDS will accept under this FOA Renewal applications to request additional years or funds to complete the original scientific aims of the exploratory clinical trial.

Funding Information

Estimated Total Funding

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Expected Number of Awards

TBD

Estimated Award Ceiling

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Primary CFDA Numbers

93.853

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
U.S. Territory or Possession
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Regional Organization
Non-domestic (non-U.S.) Entity (Foreign Organization)
Eligible Agencies of the Federal Government
Indian/Native American Tribal Government (Other than Federally Recognized)
Independent school districts
Public housing authorities/Indian housing authorities
County governments
Indian/Native American Tribal Government (Federally Recognized)
State Government
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Jeremy Brown, MD

National Institute of Neurological Disorders and Stroke (NINDS)

301-496-9135

Jeremy.brown@nih.gov