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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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Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01 Clinical Trial Not Allowed)

Published by NIH

Clinical Trial ReadinessRare diseasesBiomarkers

This 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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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

Translational ResearchClinical ResearchResearch TrainingCareer Development Program

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

Translational ResearchClinical ResearchResearch TrainingCareer Development Program

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

Translational ResearchClinical ResearchResearch TrainingCareer Development Program

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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Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required

Published by NIH

Rare diseasesNatural History StudyMedicine Development

The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.

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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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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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