Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01 Clinical Trial Not Allowed) (340330)

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Next deadline: Jan 18, 2023 (Letter of inquiry)

Later deadlines: Feb 17, 2023 (Full proposal), Jul 18, 2023 (Letter of inquiry), Aug 18, 2023 (Full proposal)

Grant amount: Up to US $750,000

Fields of work: Neurological Diseases & Disorders Neuroscience Musculoskeletal Diseases

Applicant type: For-Profit Business, Government Entity, Indigenous Group, Nonprofit

Funding uses: Research

Location of project: Preferred: United States Other eligible locations: Anywhere in the world

Location of residency: Preferred: United States Other eligible locations: Anywhere in the world

Overview:

The purpose of this FOA is to fill gaps in clinical trial readiness for rare neurological and neuromuscular conditions that will soon have candidate therapeutics ready to test in clinical trials, but, due to the lack of validated clinical outcome assessment (COA) measures or biomarkers, the success of those trials may be compromised. This FOA invites researchers to submit applications for support of multi-site, prospective clinical projects that address critical needs for clinical trial readiness in these conditions. For this FOA, clinical trial readiness is defined as having established clinically valid biomarkers and clinical outcome assessment (COA) measures that are fit-for-purpose within a defined context of use in a planned clinical trial or trials, and clinical validation of these research tools is the final step before their implementation in trials. The National Institute of Neurological Disorders and Stroke (NINDS) and the National Center for Advancing Translational Sciences (NCATS) intend to enhance the quality and increase the likelihood of success of upcoming clinical trials in these diseases by supporting studies leading to trial readiness.

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This page was last reviewed June 29, 2022 and last updated June 29, 2022