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NINDS Neuroscience Funding Announcements



NINDS Exploratory Clinical Trials (R01)

Funding Contact(s): Peter Gilbert, Sc.M.
Funding Categories: Clinical Research

Detailed Description:

Highlights of this funding opportunity:
http://grants.nih.gov/grants/guide/pa-files/PAR-10-199.html
NINDS Office of Clinical Research

  • NIH Research Project Grant (R01) grant mechanism (on SF424 (R&R) Application and Electronic Submission)
  • July 14, 2010 for the first receipt date; standard R01 dates thereafter
  • Single site or multiple site trials accepted
  • 12 page research strategy, including tables, graphs, figures, diagrams, and charts
    • For larger Phase IIb trials, CCC and DCC applications may be submitted as separate, but coordinated proposals (12 pages each)
  • Application must include the status of regulatory approvals as necessary to conduct the proposed research (e.g., open IND/IDE, or report on pre-IND/IDE meetings and IND/IDE status, or exemption letter from FDA if applicable, and/or status of RAC approval, etc)

  • Phase I trials: Evaluate and optimize the dose, formulation, safety, tolerability or pharmacokinetics of an intervention in healthy volunteers or the target population should be designed to provide important initial information regarding the intervention (e.g., safety, tolerability, dosing).
  • Phase II trials:
    • Yield data that allow a clear "go/no-go" decision regarding continued development. Proposals considered under this FOA must outline a specific plan for future development in the case of a "go" decisions (Plan for future efficacy trial)
    • Evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., biomarker activity, dose-response trends, pharmacodynamic response) 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, biological activity, or preliminary clinical efficacy (e.g., futility trials).
  • This funding announcement expects that investigators will use the NINDS Common Data Elements resource (see: http://www.commondataelements.ninds.nih.gov) when constructing data element forms

  • Appendices required (numbered in the order below):
    1. Study Protocol (see NINDS protocol template http://www.ninds.nih.gov/research/clinical_research/toolkit/protocoltemplate.htm)
    2. Recruitment feasibility (table with actual number of patients with disease seen within last 12 months by site, number of those patients who fit all entry criteria by site, proportion of patients with disease who in the past enrolled into comparable trials); and recruitment plan (written plan on how recruitment will occur and what measures are planned to reach out to physicians and patients)
    3. IRB approval at the clinical coordinating center strongly suggested at the time of submission, required at time of funding
    4. Other (only as necessary and acceptable under the NIH appendix policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html).

NINDS Office of Clinical Research



Grant Mechanism: R01
NIH Guide: PAR-10-199
Release Date: 2010-05-14
Expiration Date: 2013-05-08