NeuroNEXT Clinical Trials (U01)
Department of Health and Human Services
National Institutes of Health
Scope of the Program
This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Applications for drugs or biologics should provide compelling scientific evidence that the investigational agent proposed for study will reach/act upon the designated target or that its mechanism of action is such that it is expected to be of benefit in ameliorating a specific aspect of the disease. Neurologic diseases chosen for study must fall within the primary responsibility of NINDS (http://www.ninds.nih.gov/disorders/disorder_index.htm).
Examples of appropriate studies under this FOA include, but are not limited to, those designed to:
- Evaluate and optimize the dose, formulation, safety, tolerability or pharmacokinetics of an intervention in the target population.
- Evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., biomarker activity, pharmacodynamic response, target engagement, dose-response trends) in a human “proof of concept” trial.
- Select or rank the best of two or more potential interventions or dosing regimens to be evaluated in a subsequent trial, based on tolerability, safety data, biological activity, or preliminary clinical efficacy (e.g., futility trials).
- Evaluate biological activity relative to clinical endpoints.
- For medical devices, in addition to providing initial clinical safety data, appropriate studies are those that inform the next phase of development, usually by finalizing the device design, establishing operator technique, and/or finalizing the choice of study endpoints for the design of a pivotal clinical trial.
Studies in stroke prevention, treatment and/or recovery are not appropriate for inclusion in NeuroNEXT. All multi-site stroke studies will be conducted in the NINDS-funded stroke trials network (http://www.ninds.nih.gov/research/clinical_research/NINDS_stroke_trials_network.htm).
|Posted Date:||Mar 28, 2016|
|Last Updated Date:||Mar 28, 2016|
|Original Closing Date for Applications:||Aug 03, 2017|
|Current Closing Date for Applications:||Aug 03, 2017|
|Archive Date:||Sep 03, 2017|
|Estimated Total Program Funding:|
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
City or township governments
Public housing authorities/Indian housing authorities
Special district governments
Private institutions of higher education
Native American tribal governments (Federally recognized)
Independent school districts
Public and State controlled institutions of higher education
|Additional Information on Eligibility:||Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.|
|Agency Name:||National Institutes of Health|
|Description:||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.|
|Link to Additional Information:||http://grants.nih.gov/grants/guide/pa-files/PAR-16-155.html|
|Contact Information:||If you have difficulty accessing the full announcement electronically, please contact:
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