Research Support

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).

Applications to the Fiscal Year 2022 (FY22) Duchenne Muscular Dystrophy Research Program (DMDRP) are being solicited by the U.S. Army Medical Research Acquisition Activity (USAMRAA) using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The execution management agent for this program announcement is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC). DMDRP was initiated in 2011 to provide support for research of exceptional scientific merit and to promote the understanding, diagnosis, and treatment of Duchenne muscular dystrophy (DMD). Appropriations for the DMDRP from FY11 through FY21 totaled $49.6 million (M). The FY22 appropriation is $10.0M. The vision of the FY22 DMDRP is to preserve and improve the function and quality of life, and to extend the lifespan of all individuals with Duchenne. As such, the DMDRP seeks to support discovery and development of therapeutics for Duchenne for the benefit of military beneficiaries and the general public, from the characterization of pathophysiology through rigorous preclinical and clinical studies. Additionally, the DMDRP supports the efforts of the National Institutes of Health (NIH) Muscular Dystrophy Coordinating Committee (MDCC) and the 2015 MDCC Action Plan for the Muscular Dystrophies, which prioritizes the needs to improve treatments and reduce the disease burden for muscular dystrophy, including DMD.

The purpose of this Funding Opportunity Announcement (FOA) is to publicize a competition for Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRCs). These Centers promote collaborative basic, translational, and clinical research and provide important resources that can be used by the national muscular dystrophy research communities. The Centers also provide outstanding environments for the training of new researchers capable of addressing high priority objectives in muscular dystrophy research. Center investigators are expected to participate in important community outreach efforts to increase awareness of their research activities in the patient and advocacy communities and to incorporate community perspectives into the conduct of patient-centered research.

The purpose of this Funding Opportunity Announcement (FOA) is to publicize a competition for Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRCs). These Centers promote collaborative basic, translational, and clinical research and provide important resources that can be used by the national muscular dystrophy research communities. The Centers also provide outstanding environments for the training of new researchers capable of addressing high priority objectives in muscular dystrophy research. Center investigators are expected to participate in important community outreach efforts to increase awareness of their research activities in the patient and advocacy communities and to incorporate community perspectives into the conduct of patient-centered research.