Funding Opportunities

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

The purpose of this Funding Opportunity Announcement (FOA) is to promote the development of fit-for-purpose candidate biomarkers and biomarker signatures that enable more efficient clinical trials to advance therapeutic development or be used in clinical practice to help guide clinical care decisions. Specifically, the goal of this phased funding mechanism is to first identify or confirm candidate biomarkers or biomarker signatures using human samples and/or data, followed by an independent retrospective or prospective clinical study to conduct initial clinical validation of the biomarker/signature’s clinical utility for a defined Context of Use(s). In the first phase, applicants are expected to demonstrate that the biomarker acceptably identifies or predicts the concept of interest and may include optimization of the detection method using carefully standardized human samples or datasets. The overarching purpose of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.

*Multiple due dates - see FOA

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice.  Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required.

The purpose of this notice of funding opportunity (NOFO) is to support rigorous development and validation of Digital Health Technology (DHT) derived biomarkers or clinical outcome assessments (COAs) for remote monitoring to fill a defined unmet clinical endpoint for interventional clinical trials. To increase standardization and improve clinical adoption, applicants must propose to develop and evaluate the DHT enabled biomarkers or COAs in three or more diseases or conditions. Applicants must also propose to conduct development studies that are informed by people with lived experience (PWLE) and patient advocacy organizations. The first phase of this funding mechanism is to evaluate the technical performance of the proposed DHTs withPWLE input; the second phase is to support a prospective longitudinal clinical study in representative populations to validate the DHT. Research outcomes should include demonstrating how a meaningful change in the biomarkers or COAs derived from the DHT(s) can be statistically measured and quantified at the individual participant level.

*Multiple due dates - see FON

The purpose of this notice of funding opportunity (NOFO)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.