The Network for Excellence in Neuroscience Clinical Trials is designed to increase the efficiency of clinical trials, to facilitate patient recruitment and retention, to increase the quality of neuroscience clinical trials, and to enable public-private partnerships. The network will include multiple Clinical Sites (RFA-NS-11-008), one Clinical Coordinating Center (CCC) (RFA-NS-11-009), and one Data Coordinating Center (DCC) (RFA-NS-11-010). The network aims to share expertise and infrastructure across diseases, to leverage research resources at clinical sites, and to flexibly take advantage of clinical research opportunities as they arise in different disease areas. This clinical research network will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. Finite resources and - especially for rare diseases - a small pool of potential participants limit the number of large, confirmatory efficacy (Phase 3) trials that can be conducted at any given time. Therefore, NINDS aims through the network to support exploratory trials that can provide more rapid preliminary testing of new treatments.
The objective of the network is to streamline the implementation of clinical research by using standardized master trial agreements and infrastructure that utilizes a central IRB of record. While NINDS has historically funded trials to test drugs already approved for other indications, the network is designed to assure the broadest access to any new therapies for patients by carrying out trials coming from partnerships between NINDS and industry, foundations, or academia. These trials will be utilizing a variety of the NIH agreement mechanisms that maximize industry participation and support.
While the network will not be specific to one disease, it will have the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities.
To apply to the solicitations for infrastructure for this initiative, please visit the NIH Guide and respond to the Requests for Applications (RFAs) for the Network of Excellence in Neuroscience Clinical Trials.
The NINDS will hold a technical assistance meeting on December 17, 2010 (NOT-NS-11-005), through a teleconference to which all interested prospective applicants are invited. Program and review staff will make presentations that explain their goals and objectives for the initiative and answer questions from the attendees. Questions prior to and during the meeting may be submitted to NEXT@ninds.nih.gov.
The application deadline for all three RFAs is March 11, 2011.
Last updated June 2, 2011