NeuroNEXT, a NINDS initiative to conduct Phase 2 trials in neurological conditions, receives proposals from academics, foundations and industry. All proposals are evaluated for mission relevance and institute priority by NINDS and for network feasibility by the NeuroNEXT Executive Committee (NEC). All proposals which are found to be mission relevant, feasible and of sufficient institute priority are referred to protocol working groups (PWG) for development of grant applications. The NINDS, NEC and PWG do not make any determination as to scientific merit; applicants should be aware that the fact that NeuroNEXT is submitting a proposal for review is no guarantee of funding approval. The scientific review of the proposal occurs after the grant application has been submitted for peer- and council-review. Funding decisions are made based on the results of those reviews.

Clinical Sites (FOA RFA-NS-11-008)

How many of the 25 trial sites do you envision will be involved in a disease-specific project?
The number of sites involved will vary between projects; it will depend on the total number of participants to be enrolled in a specific project, and the likelihood that a given site can enroll a sufficient number of participants meeting the entry criteria based on their clinic populations.
Will the clinical sites be able to support several studies concerning a broad array of disorders at once?
A clinical site may participate in more than one study if they have expertise and patients in the different disease areas. The coordinator and investigator supported by the Clinical Site network grant will work with disease-specific investigators to support several trials.
The RFA is unclear as to the exact scope and distribution of study topics: will neuro-oncology clinical trials be included?
Brain tumor trials are primarily supported by the National Cancer Institute (NCI) and its existing clinical research infrastructure. Therefore, it is likely that the new NINDS network would execute a brain tumor trial only in exceptional circumstances.
Will network sites have access to data?
The projects will follow the NIH Data Sharing Policy.
If selected network sites chose not to participate in a network-approved study protocol, how will the sites be guaranteed of not losing their infrastructure funding?
If a site with capacity repeatedly chose not to participate in network-approved study protocols, they could lose funding and be removed from the network for poor performance.
Is there any restriction on the use of ad-hoc sites? For instance, if a project PI is from a non-network site, might he/she be prevented from recruiting patients locally?
The use of ad-hoc sites has to be well justified scientifically and in terms of recruitment feasibility. Including the project PI’s site as ad-hoc site (if the PI is not part of network) is expected if the PI has the capacity at his/her site.
Are international sites, in any capacity, permissible in NeuroNEXT?
Yes. International sites may be added ad hoc, if justified scientifically, and absolutely necessary for recruitment. These sites (without a foreign PPI) would be given the same consideration as any other ad hoc site. Additionally, foreign investigators are permitted to submit proposals, though they must use the NeuroNEXT infrastructure in addition to their home site.

FAQS