Highlights of this funding opportunity:
NINDS Office of Clinical Research
- NIH Research Project Grant (R01) grant mechanism (on SF424 (R&R) Application and Electronic Submission)
- September 5, 2013 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)
- 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 healthy volunteers or the target population.
- Evaluate whether an intervention produces sufficient evidence of short-term activity (e.g., biomarker activity, target engagement, 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).
Due to the broad scope of possible medical devices and the varied nature of the regulatory path, investigators considering applications to evaluate devices are strongly encouraged to contact Program Staff as early as possible to discuss plans for medical device trials.
- This funding announcement expects that investigators will use the NINDS Common Data Elements resource when constructing data collection forms
- Appendices required (in the order listed below):
- Clinical Protocol. The final version of the study protocol must be included as Appendix I. Applications that do not include a full protocol are incomplete and will not be reviewed.
- Informed consent form(s) (ICFs) and, if applicable, assent form(s). The applicant should consider including language in the ICF to allow broad data and specimen access for subsequent research in order to maximize the value of subject samples and data and accelerate progress beyond the trial itself. (See http://www.ninds.nih.gov/research/clinical_research/application_process/index.htm for suggested ICF language)
- Listing of clinical sites, pharmacies, and laboratories
- Copy of the Investigator’s Brochure or equivalent for the study product
- Documentation of availability of investigational agent(s) as well as plans and support for acquisition and distribution of investigational agent(s)
- Documentation of availability of eligible subjects at clinic sites, presented in tabular format. As required by the NINDS Guidelines for Enrollment of Subjects into NINDS-Funded Clinical Trials (see http://grants.nih.gov/grants/guide/notice-files/NOT-NS-05-010.html), the application must include relevant information that addresses the feasibility of recruiting participants who are eligible for the clinical trial. Specifically, applicants must provide evidence that each recruiting center in the trial has access to a sufficient number of study participants who meet the eligibility criteria as defined in the submitted protocol. For multi-site applications, information must be provided for each site participating in the trial. This information must be included in the Research Strategy section of the application, as well as the appendix.
Before submitting an application to this FOA, applicants should follow the instructions on the NeuroNEXT website to obtain feedback on the suitability of their trial for the NeuroNEXT network.
NINDS Office of Clinical Research