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NeuroNEXT Clinical Trials (U01 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Wednesday, March 6, 2024
U01
PAR-21-223
Codrin Lungu

Funding Opportunity Purpose

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.

NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Saturday, April 6, 2024
U44
PAR-21-224
Codrin Lungu

Funding Opportunity Purpose

This 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.

Notice of Special Interest (NOSI): Administrative Supplements to Promote Diversity for NINDS Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) Awardees

Notice of Special Interest
Thursday, April 22, 2021
Sunday, March 31, 2024
333
NOT-NS-21-047

Funding Opportunity Purpose

The purpose of this NOSI is to encourage eligible NINDS awardees in the Alzheimers Disease and Alzheimers Disease-Related Dementias (AD/ADRD) research community to apply for administrative supplements in response to PA-21-071, "Research Supplements to Promote Diversity in Health-Related Research," or any reissues of this announcement through the expiration date of this Notice. The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031 for details) and encourages institutions to diversify their student populations by enhancing the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Goal 1 of The National Plan to Address Alzheimers Disease is to prevent and effectively treat AD/ADRD by 2025. This initiative addresses the critical need to increase the number of health professionals who are trained to meet the expanding demand for cognitive impairment and dementia diagnosis, care, and clinical research to meet Goal 1.

HEAL Initiative: Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Wednesday, October 11, 2023
U19
RFA-NS-21-015

Funding Opportunity Purpose

This funding opportunity announcement (FOA) is part of a suite of FOAs to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal of this FOA is to support team-based research projects to develop assays, screening and early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and validation of pharmacodynamic markers efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies are also responsive. The result of the project should be to advance a hit or lead to the point where they can meet the entry criteria for RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) within the 5 years of the award, there is no opportunity for renewal of this award. Applications should propose a plan that will lead to the development of analgesics with a rigorous biological rationale and scientifically sound assays. If the data does not currently exist, the proposal must include a strong plan for developing data linking the putative therapeutic target(s) to the proposed pain indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease. This FOA is not specific for any one or group of pain conditions. Projects to develop therapeutics for acute pain, chronic pain, painful neuropathy, musculoskeletal pain, headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, eye pain, sickle-cell pain, post-surgical pain, cancer pain, visceral pain, post stroke pain, myofascial pain, painful disorders of the orofacial region and other conditions will be considered.

HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Heal
Wednesday, October 11, 2023
R34
RFA-NS-21-016

Funding Opportunity Purpose

The goal of this funding opportunity announcement (FOA) is to solicit Initial Analgesic Development R34 applications that propose 2-year exploratory/planning awards that are expected to enable a future application for RFA-NS-21-015 HEAL Initiative: Team Research - for Initial Translational Efforts in Non-addictive Analgesic Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed). Thus, the limited scope of aims and approach of these applications are expected to establish a strong research team, feasibility, validity, or other technically qualifying results that support, enable, and/or lay the groundwork for a subsequent Team Research U19 application. These R34 awards will support the building of a research team to collect initial data and recruit additional collaborators. The proposal must include a plan for developing a strong research team, as well as a strategy to collect preliminary data linking putative therapeutic targets to the proposed pain indication and supporting the hypothesis that altering target activity will produce desirable outcomes for the disease.

HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development (U19 Clinical Trial Not Allowed)

RFA
Thursday, March 11, 2021
Heal
Wednesday, October 11, 2023
U19
RFA-NS-21-015

Funding Opportunity Purpose

This funding opportunity announcement (FOA) is part of a suite of FOAs to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal of this FOA is to support team-based research projects to develop assays, screening and early optimization work to develop a non-addictive therapeutic to treat pain. Discovery and validation of pharmacodynamic markers efficacy and pharmacokinetic/pharmacodynamic (PK/PD) studies are also responsive. The result of the project should be to advance a hit or lead to the point where they can meet the entry criteria for RFA-NS-21-010 HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional) within the 5 years of the award, there is no opportunity for renewal of this award. Applications should propose a plan that will lead to the development of analgesics with a rigorous biological rationale and scientifically sound assays. If the data does not currently exist, the application must include a strong plan for developing data linking the putative therapeutic target(s) to the proposed pain indication and supporting the hypothesis that altering the target activity will produce desirable outcomes for the disease. This FOA is not specific for any one or group of pain conditions. Projects to develop therapeutics for acute pain, chronic pain, painful neuropathy, musculoskeletal pain, headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, eye pain, sickle-cell pain, post-surgical pain, cancer pain, visceral pain, post stroke pain, myofascial pain, painful disorders of the orofacial region and other conditions will be considered. Projects to develop analgesics for a combination of chronic overlapping pain conditions or for specific disease or pathological conditions will also be considered. Projects that seek to identify pain treatment targets in specific populations such as women, children, older adults, and other underrepresented groups will also be responsive to this FOA. Input from patients and caregivers on the therapeutic goals of the project is encouraged. The goal of each 5-year U19 application should be to identify candidate therapeutic(s) that will be ready to be submitted to RFA-NS-21-010 for further optimization.

NIH Blueprint for Neuroscience Research: Tools and Technologies to Explore Nervous System Biomolecular Condensates (R21 Clinical Trial Not Allowed)

RFA
Monday, January 25, 2021
Thursday, September 16, 2021
R21
RFA-DA-22-008

Funding Opportunity Purpose

To support the development of innovative tools and/or technologies to monitor or manipulate BMCs in vivo and enable investigators to adopt these tools to answer outstanding questions in basic neuroscience. This research will transform our understanding of the mechanistic role of BMCs in human nervous system health and disease and may serve as the foundation for the development of novel BMC-based therapeutics.

Music and Health: Understanding And Developing Music Medicine (R01 Clinical Trial Optional)

PAR
Wednesday, December 23, 2020
Monday, February 6, 2023
R01
PAR-21-100
Robert Riddle

Funding Opportunity Purpose

This FOA is intended to: (1) increase our understanding of how music affects the brain when it is used therapeutically and/or (2) use that knowledge to better develop evidence-based music interventions to enhance health or treat specific diseases and disorders. Proposed R01 projects can investigate how music is processed by or modifies the brain, or how it affects specific biological functions during childhood development and learning, adulthood, and aging. Projects can also include preliminary interventions that provide a basis for therapeutic interventions. When appropriate, collaborations among basic researchers, technology developers, music intervention experts, or other clinical researchers are highly encouraged.

Music and Health: Understanding And Developing Music Medicine (R21 Clinical Trial Optional)

PAR
Wednesday, December 23, 2020
Friday, February 17, 2023
R21
PAR-21-099
Robert Riddle

Funding Opportunity Purpose

This FOA is intended to: (1) increase our understanding of how music affects the brain when it is used therapeutically and/or (2) use that knowledge to better develop evidence-based music interventions to enhance health or treat specific diseases and disorders.

New Chemistries for Un-drugged Targets through A Specialized Platform for Innovative Research Exploration (ASPIRE) Collaborative Research Program (UG3/UH3 Clinical Trials Not Allowed)

RFA
Sunday, December 20, 2020
Heal
Friday, July 9, 2021
UG3/UH3
RFA-TR-21-001

Funding Opportunity Purpose

The purpose of the ASPIRE Collaborative Research Program is to facilitate translational and clinical research between NCATS intramural scientists and the extramural community to develop approaches that will enhance the ability to discover and develop new chemistries towards previously undrugged biological targets (i.e., biological targets with no known drugs to modulate their function) across many human diseases and conditions. NCATS intramural scientists have established an integrated NCATS ASPIRE platform consisting of physical and virtual modules for automated synthetic chemistry, artificial intelligence (AI) and machine learning (ML), engineering, informatics, and biological testing. The FOA will support intramural - extramural collaborations to develop additional physical modules that will enhance the platform’s capabilities. The anticipated outcome includes identification, design, synthesis, and validation of new chemical entities as starting points for drug development of novel targets, and the expansion of chemical space available for drug screening.

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