NINDS is offering the NeuroNEXT Clinical Trials Grant to support exploratory clinical trials of investigational agents related to NINDS’ strategic plan. The grant aims to provide data for designing future trials, biomarker validation studies, or proof of mechanism clinical studies. Successful applicants will have access to the NeuroNEXT infrastructure, including the Clinical Coordinating Center and Data Coordinating Center for support in implementing the proposed study. Clinical sites will assist with recruitment/retention. Applicants do not need to be part of the existing NeuroNEXT infrastructure. Closing date for applications is April 04, 2016.
Opportunity ID: 241456
General Information
| Document Type:: | Grants Notice |
| Funding Opportunity Number:: | PAR-13-343 |
| Funding Opportunity Title:: | NeuroNEXT Clinical Trials (U01) |
| Opportunity Category:: | Discretionary |
| Opportunity Category Explanation:: | |
| Funding Instrument Type:: | |
| Category of Funding Activity:: | Health |
| Category Explanation:: | |
| Expected Number of Awards:: | |
| Assistance Listings Number(s):: | 93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders |
| Cost Sharing or Matching Requirement:: | No |
| Version:: | Synopsis 2 |
| Posted Date:: | Aug 30, 2013 |
| Last Updated Date:: | Sep 17, 2015 |
| Original Closing Date for Applications:: | Dec 03, 2015 |
| Current Closing Date for Applications:: | Apr 04, 2016 |
| Archive Date:: | May 04, 2016 |
| Estimated Total Program Funding:: | |
| Award Ceiling:: | $ |
| Award Floor:: | $ |
Eligibility
| Eligible Applicants:: | Native American tribal organizations (other than Federally recognized tribal governments) |
| 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) and foreign components of U.S. Organizations are eligible to apply, but will have to work with the U.S.-based NeuroNEXT infrastructure.Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 2 | Modified the close date, in accordance with NOT-NS-15-042. | Sep 17, 2015 |
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.853 |
| Competition ID: | FORMS-C |
| Competition Title: | Forms-C |
| Opportunity Package ID: | PKG00184472 |
| Opening Date: | Nov 02, 2013 |
| Closing Date: | Apr 04, 2016 |
| Agency Contact Information:: | eRA Commons Help Desk |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V2.0] PHS 398 Research Plan [V2.0] PHS 398 Cover Page Supplement [V2.0] Research and Related Senior/Key Person Profile (Expanded) [V2.0] Research And Related Other Project Information [V1.3] Project/Performance Site Location(s) [V2.0] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.3] Planned Enrollment Report [V1.0] PHS 398 Cumulative Inclusion Enrollment Report [V1.0] PHS 398 Modular Budget [V1.2] Research & Related Budget [V1.3] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.853 | FORMS-C | Forms-C | PKG00184472 | Nov 02, 2013 | Apr 04, 2016 | View | eRA Commons Help Desk | Organization Applicants |