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NICHD Research Education Programs (R25 Clinical Trial Not Allowed)

Published by NIH

Educational ProgrammeResearch ExperienceSkill Development

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

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Pilot Projects Investigating Understudied Proteins Associated with Rare Diseases (R03 Clinical Trial Not Allowed)

Published by NIH

Rare diseasesUnderstudied Proteins

The purpose of this funding opportunity announcement (FOA) is to solicit applications for pilot projects to elucidate a role for understudied proteins associated with rare diseases. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s). A list of eligible proteins is provided and are members of druggable protein families that have a known association with a rare disease. This FOA is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins associated with rare disease.

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Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed)

Published by NIH

Career Development ProgramClinical ResearchResearch TrainingTranslational Research

The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions to enhance predoctoral research training of individuals seeking a PhD or an equivalent research health professional degree and help ensure a heterogenous pool of clinical and translational scientist trainees who are equipped with the knowledge, skills and abilities to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications aimed at improving health.

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Limited Competition: NCATS Clinical and Translational Science Award (CTSA) Program Research Education Grants Programs (R25 – Clinical Trial Not Allowed)

Published by NIH

Career Development ProgramClinical ResearchResearch TrainingTranslational Research

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.

To accomplish the stated overarching goal, this FOA will provide support to recipients of Clinical and Translational Science Awards (CTSA) for creative educational activities with a primary focus on research experiences designed to ensure that the participants receive exposure to the scientific and operational principles underlying each step of the translational process so that they can apply these principles to clinical and translational science research areas such as: 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and 4) public health.

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Limited Competition: Mentored Research Career Development Program Award in Clinical and Translational Science Awards (CTSA) Program (K12 Clinical Trial Optional)

Published by NIH

Career Development ProgramClinical ResearchResearch TrainingTranslational Research

The National Center for Advancing Translational Sciences (NCATS) will award Institutional Research Career Development (K12) programs through the Clinical and Translational Science Awards (CTSA). The purpose of this Funding Opportunity Announcement (FOA) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare an outstanding heterogeneous pool of promising later stage postdoctoral fellows and junior faculty scholars in clinical and translational science who have made a commitment to independent research careers (i.e., tenure-track or equivalent faculty positions), and to facilitate their timely transition to more advanced support mechanisms, e.g., K08, K23, R01, R03, etc. Applicants must submit both a UM1 application to PAR-21-293: Clinical and Translational Science Award and a K12 application to this FOA.

This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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NeuroNEXT Clinical Trials (U01 Clinical Trial Optional)

Published by NIH

Clinical TrialInvestigational Medicinal ProductRare diseases

This FOA encourages 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 a future trial, for biomarker validation studies, or for proof of mechanism 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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Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 – Clinical Trial Optional)

Published by NIH

Gene TherapyUltra Rare Disease

The 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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Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access (X01, Clinical Trial Not Allowed)

Published by NIH

Gene TherapyUltra Rare Disease

The purpose of this FOA is to provide investigators with a mechanism to access contract research/medical organizations (CROs/CMOs) and subject matter experts (SMEs) within the NINDS Ultra-Rare Gene-based Therapy (URGenT) Network to support planning, manufacturing, and limited nonclinical therapeutic development efforts.

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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 Needs

The 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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