This clinical research network develops and conducts multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries.
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NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
Published by NIH
and Fast-TrackPhase IISmall Business Innovation Research (SBIR) Grant - Phase IThe purpose of this notice of funding opportunity (NOFO) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies.
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Cellular and Molecular Biology of Complex Brain Disorders
Published by NIH
Exploratory/Developmental Research GrantThis Notice of Funding Opportunity (NOFO) encourages research on the biology of high confidence risk factors associated with complex brain disorders, with a focus on the intracellular, transcellular and circuit substrates of neural function. For the purposes of this NOFO , the term “complex” can refer to a multifactorial contribution to risk (e.g., polygenic and/or environmental) and/or highly distributed functional features of the brain disorders
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Limited Competition: Small Grant Program for the NCATS Clinical and Translational Science Award
Published by NIH
Small Grant ProgramThe purpose of this NOFO is to enhance the capability of NCATS CTSA Program KL2/K12 scholars and recipients of diversity and re-entry supplements (Research Supplements to Promote Diversity in Health-Related Research (Admin Supp – Clinical Trial Not Allowed) (PA-23-189 and PA-21-071)) and Research Supplements to Promote Re-Entry, Re-integration into, and Re-training in Health-Related Research Careers (Admin Supp – Clinical Trial Not Allowed) (NOT-OD-23-170 and NOT-OD-21-134)) supported by the CTSA Program to conduct translational science research as they complete the transition to fully independent academic translational scientists.
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Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders
Published by NIH
Research Project Cooperative AgreementsThe Ultra-Rare Gene-Based Therapy (URGenT) network supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human (FIH) clinical testing of gene-based or transcript-directed therapeutics, such as oligonucleotides and viral-based gene therapies, for ultra-rare neurological or neuromuscular disorders. The goal of this funding opportunity announcement (FOA) is to accelerate the development of a promising clinical candidate with robust biological rationale and demonstrated proof of concept (POC) data for the intended approach in a model system relevant to a specified patient population towards an IND filing and the initiation of a clinical trial.
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NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)
Published by NIH
Clinical TrialInvestigational Medicinal ProductRare diseasesThis Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm).
Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.
Applicants do not need to be part of the existing NeuroNEXT infrastructure.
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NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
Published by NIH
Clinical TrialsRare diseasesSmall Business Innovation ResearchThe purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies.
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Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
Published by NIH
Clinical TrialRare diseasesUnmet NeedsThe purpose of this funding opportunity announcement (FOA) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.
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HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 Clinical Trial Not Allowed)
Published by NIH
Pain ManagementScreening ToolsTherapies and TechnologiesThe purpose of this Funding Opportunity Announcement (FOA) aims to speed scientific solutions to stem the national opioid public health crisis by supporting the development of therapies and technologies directed at enhanced pain management through the Small Business Innovation Research (SBIR) program. This FOA is focused on applications directed at improving pain treatment, including the development of new non-addictive medications and devices and objective pain measurement. In addition, NIH is interested in new screening tools and models focused specifically on pain and development of pain therapies.
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Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01 Clinical Trial Not Allowed)
Published by NIH
BiomarkersClinical Trial ReadinessRare diseasesThis Funding Opportunity Announcement (FOA) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials, and to increase their likelihood of success through development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.
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