The UCLA Stroke Center at Ronald Reagan UCLA Medical Center has joined a network of 25 regional stroke centers to address the three prongs of stroke research: prevention, treatment and recovery. The network will span the country, and have teams of researchers representing every medical specialty needed for stroke care. The Centers were announced today by the National Institutes of Health. “The new system is intended to streamline stroke research, by centralizing approval and review, lessening time and costs of clinical trials, and assembling a comprehensive data sharing system,” said Petra Kaufmann, M.D., the associate director for clinical research at the National Institute of Neurological Disorders and Stroke (NINDS).
NINDS, which will fund and manage the NIH Stroke Trials Network, or NIH StrokeNet, has a strong history of successful stroke clinical trials over the past 40 years, leading to some astonishing advances in treatment and prevention of the disease, including the first treatment for acute stroke, announced in 1995. The 25 centers are strategically placed in every region of the country, (a complete list of centers their principal investigators, and media contacts is attached). Successful applicants demonstrated experience in stroke research and recruitment, including the ability to enroll underrepresented populations, and were required to offer access to the full cadre of specialties that are involved in stroke care. These include: emergency medicine, neurosurgery, interventional neuroradiology, vascular neurology, neurointensive care, neuroimaging, stroke rehabilitation and pediatric neurology. Last October, UCLA joined forces with the USC Comprehensive Stroke and Cerebrovascular Center at Keck Medicine of USC, and UC Irvine, to form the Los Angeles–Southern California Regional Coordinating Center, which will marshal a network of 49 acute stroke and rehabilitation medical centers throughout Los Angeles and Orange counties. Combined, these centers will perform five to 10 stroke-related clinical trials that will examine ways to improve prevention and enhance therapies and recovery. Within this network, 12 working groups with expertise in specific neurovascular research will facilitate the implementation of these trials and serve as a resource to the Regional Coordinating Center’s leadership and the individual sites.
The Los Angeles–Southern California Regional Coordinating Center was well-positioned to join the NINDS Network, said Dr. Jeffrey Saver, director of the UCLA Stroke Center and a professor of neurology. “This research network is built upon the robust foundation of two decades of cooperative clinical care and clinical trials in cerebrovascular disease in Southern California,” he said. “The close collaboration of all three academic medical centers in the region — UCLA, USC and UCI — represents a natural and important evolution of our extensive past collaborations.” Each center will receive five-year funding, with $200,000 in research costs and $50,000 for training stroke clinical researchers per year over the first three years, and additional funds driven by the completion of milestones. The University of Cincinnati will manage the national clinical coordinating center, which will oversee and coordinate the institutional review board and master trial agreements for all of the regional centers. NIH will announce the award of a national data management center in February.
NIH StrokeNet investigators, working with the broader stroke community, will propose, develop and conduct stroke protocols to be administered within the network and train the future generation of clinical researchers in stroke. Historically, the model for stroke clinical trials was to complete large teams of personnel and infrastructure, which were then disassembled once the trial was completed. This led to delays in patient recruitment and additional costs when new trials were initiated, with some stroke clinical trials lasting many years longer than anticipated and costing millions of dollars more than the original estimate.
In a 2013 article in Stroke, Story Landis, Ph.D., NINDS director, and co-author Marc Fisher, M.D. write: “Because our ultimate goal is to test and compare therapies that will have a real impact on patient health, a coordinated and long range approach to solving challenges in stroke trial research is sorely needed.”The network concept evolved from an NINDS planning effort in which stroke experts were asked what is most needed to reduce death and disability due to stroke in the United States. They called for a nationwide stroke network that would allow for a more seamless transition between early safety and efficacy trials and Phase II and III clinical trials.
“NIH StrokeNet will allow the most promising therapies to quickly advance to the clinic, to improve prevention, acute treatment, or rehabilitation of the stroke patient,” said Walter J. Koroshetz, M.D., NINDS deputy director. “We need to have a balance of approaches to decrease the burden of illness due to stroke.”