Funding Opportunities

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, which should include evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders and conditions. Specifically, the goal of this PAR is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

This funding opportunity announcement (FOA) aims to stimulate innovative multi-disciplinary collaboration and secondary analyses of existing clinical research datasets, from two or more multi-site clinical research studies, for addressing scientific and/or clinically relevant hypotheses that have the potential to address knowledge gaps to inform future clinical trials and/or improve clinical care in research areas within the NINDS mission. For purposes of this FOA, “existing clinical research datasets” refers to datasets from clinical trials, natural history studies, and / or comparative effectiveness research studies but excludes “mechanistic clinical studies” and “basic experimental studies of humans” (for definitions see https://grants.nih.gov/grants/guide/notice-files/NOT-NS-18-011.html and https://grants.nih.gov/grants/glossary.htm#BasicExperimentalStudieswithHumans, respectively). This FOA will support the harmonization, curation and analyses of datasets from two or more multi-site clinical research studies to conduct additional secondary analyses; it will not support the collection of new data.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS) to establish the efficacy (or compare the effectiveness) of treatment interventions.  These Phase 3, Phase 4 or Pivotal 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 surgical, behavioral or rehabilitation therapies.

*Multiple due dates - see FOA