NINDS held an initial investigator meeting recently to bring together all of the NeuroNext PIs.
NINDS recently launched its Network for Excellence
in Neuroscience Clinical Trials, or NeuroNext,
to conduct exploratory (phase II) trials
of treatments for neurological diseases. The new initiative directed by NINDS associate
director for clinical research Dr. Petra Kaufmann is designed to expand capability to test the most promising new therapies and increase the efficiency of clinical trials before embarking on large efficacy studies through partnerships with academia, private foundations
and industry. NeuroNext also will respond quickly as new opportunities arise to test promising
treatments for people with neurological disorders.
“NINDS has learned that one of the best ways to decrease the time and cost of clinical research is through well-coordinated networks,” said NINDS director Dr. Story Landis. “NeuroNext allows us to efficiently test new treatments, to move promising therapies along the pipeline and to provide the expertise and resources that are needed for rapid implementation of large clinical trials.”
In October 2011, NINDS made awards to 25 U.S. clinical sites, a clinical coordinating center
and a data coordinating center. It also announced the program in a series of meetings with academic researchers, industry representatives
and patient advocacy groups. In November 2011, the institute brought together all of the NeuroNext principal investigators for the first time. The meeting covered topics such as site management, web site development, educational
opportunities, network performance metrics
and the roles and responsibilities of the PIs, coordinators and institutional review board.
The network is spread across the country to maximize clinical research participation. The majority of sites are at institutions with Clinical
Translational Science Awards funded by the National Center for Advancing Translational Sciences. Trials will focus on neurological disorders
in adults and children. Because NINDS’s research portfolio includes hundreds of disorders,
NeuroNext will not be specific to one disease.
However the broad spectrum of neuro subspecialists in the network will enable it to move quickly to design and execute research on a wide variety of neurological disorders.
Historically, two issues—variability in access to powerful clinical research infrastructure (especially
for rare diseases) and ability to secure intellectual property—have limited testing of new therapies coming from discoveries
in neuroscience. NeuroNext will make a strong clinical research infrastructure
available for a wide variety of diseases and include exploratory trials based on cooperative research and development agreements between NINDS and industry partners. NeuroNext’s broad partnerships should ensure more rapid
access to new therapies for patients.
One innovative feature of NeuroNext is use of a centralized IRB. Trials at multiple
centers have traditionally required full review at each participating center, which can result in slowdowns and inefficiencies.
The Data Coordinating Center is housed at the University of Iowa and the Clinical
Coordinating Center will be operated by Massachusetts General Hospital. For more information, go to www.ninds.nih.gov/NeuroNext.