Data Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT - DCC) (U01 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
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. 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 trials that can provide more rapid preliminary testing of new treatments.
The network will streamline the implementation of clinical research by using standardized master trial agreements and infrastructure that utilizes a central IRB of record, and 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.
Shared network infrastructure:
This FOA encourages applications for funding of infrastructure for data and statistical coordination. The additional project-specific funds to support the implementation of network protocols will be part of future awards.
Responsibilities of the DCC include the following:
- The DCC will provide full statistical support from trial conception, design, implementation (including but not limited to randomization), to interim analysis, final analysis, and publication; The DCC will lead the design and implementation of master protocols where appropriate for specific studies;
- The DCC will also provide full data management support from conception, planning, building a trial database with user-friendly, web-based data entry, data quality control, data monitoring, preparation of reports for the Data and Safety Monitoring Board (DSMB) and analyses, data lock, data cleaning, and preparing datasets for submission to an NINDS data repository;
- The DCC will provide support for web-based communication and access to study-wide information (e.g., protocol amendments), as well as for a public website for each trial to promote outreach and recruitment.
Network trials:
Project proposals from industry and academic investigators are submitted in response to separate announcements, and are selected for funding through the standard NINDS process as outlined in the related announcements.
The network trials utilize a variety of the NIH agreement mechanisms (e.g., Cooperative Research and Development Agreements [CRADAs]) that maximize industry participation and support.
Following a second level of review by the NINDS advisory council, NINDS will select protocols to be fully developed by a protocol lead team consisting of the Project Director/Principal Investigator (PD/PI), disease-experts as co-investigators, and network representatives. Patient representatives and patient advocacy groups must be included in the protocol development process and in review of manuals of operation as well as organizational and oversight committees.
The final protocol will be approved after technical review by a Protocol Review Committee. A subset or all of the Clinical Sites will then be invited to participate in a given project and will have the option to accept or decline, depending on their capacity, interest, and patient population relevant to the specific protocol. It is also possible that non-network sites may be added ad-hoc for a specific project, for their expertise and patient population to complement network sites.
The expected direct cost for individual awards is up to $1,300,000 per project year.
November 21, 2022
Joan Ohayon, RN, MSN, CRNP, MSCN, National Institute of Neurological Disorders and Stroke (NINDS), Telephone: 301-496-9135, Email:ohayonj@ninds.nih.gov