Research Support

Funding Opportunities

Title Description Expires Grant Number
Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01 Clinical Trial Not Allowed)

This Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical studies that address critical needs for clinical trial readiness in rare neurological and neuromuscular diseases. These studies should result in clinically validated biomarkers and clinical outcome assessment measures appropriate for use in upcoming clinical trials. Through the support of trial readiness studies, NINDS expects to enhance the quality and increase the likelihood of success of clinical trials in these rare diseases.

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.

The initiative will promote partnerships among academic investigators, industry, and patient groups, and will encourage interactions with the Food and Drug Administration (FDA).

PAR-22-184

Information for Researchers

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