NIH Hopes to Revolutionize Process through National NetworkEveryone wants to build a better mousetrap ... but building it over and over again isn't very efficient. Finding a way to keep the 'mousetrap' infrastructure in place while adding new features based on a collective body of knowledge is fundamentally the basis of the new National Institutes of Health Stroke Trials Network.Funded and managed by the National Institute of Neurological Disorders and Stroke (NINDS), NIH StrokeNet is focused on the three prongs of stroke research -- prevention, treatment and recovery. The new structure utilizes a network of academic medical centers across the country working with nearby satellite facilities to coordinate and streamline stroke research by centralizing approval and review, while creating a comprehensive data-sharing system. The network also is expected to lessen the time required to set up clinical trials since the infrastructure will already be in place, thereby making research more efficient and less costly. Scott Janis, PhD, program director in the Office of Clinical Research at NINDS and the scientific director for NIH StrokeNet, explained, "We identified 25 geographically distributed regional centers and identified over 200 hospitals that will be part of the network. Many are primary stroke centers, but many are community hospitals aligned with the regional stroke participant." The 25 lead sites were chosen based on a demonstration of past experience in stroke research and recruitment, including the ability to enroll underrepresented populations. Each center has been granted five-year funding with $200,000 in research costs and $50,000 for training stroke clinical researchers per year over the first three years. The completion of milestones will drive additional funding. The University of Cincinnati has been named the national clinical coordinating center. With the new structure in place, Janis said it should be possible to more rapidly add studies to the pipeline. NIH StrokeNet also creates a central institutional review board and has a built-in master trial agreement to further expedite launching new trials.Janis also noted the network calls on a truly intraprofessional team of providers and researchers -- from first responders and emergency room physicians to the specialists caring for patients acutely all the way through to ambulatory rehabilitative therapists. By having a coordinated team across the continuum of care, including pediatric specialists in the 25 regional centers, the hope is that stroke patients will be rapidly identified and more easily followed throughout their journey. "This network fosters communication in a collaborative way," he said. "We can't control when someone has a stroke, but we can control our ability to identify them for a potential study."Previously, the model for stroke clinical trials happened in a stand-alone manner. A large team, often over multiple centers across the country, had to be assembled, and the infrastructure set up for each trial. Then, once completed, the entire team had to be disassembled only to start the process all over again for the next study. The cumbersome method led to delays in patient recruitment and repeated costs to initialize new projects. Sometimes those delays caused a stroke trial to go much longer than initially anticipated, costing millions of dollars more than the original estimate."That effort in building and tearing down, building and tearing down, doesn't efficiently allow us to ask the questions to move the science forward," Janis said. Drug research to control stroke risk factors has improved to the point that Janis said sometimes the medicine had moved on by the time a stroke trial that had undergone delays managed to wind down. "You really want to get to answers more rapidly," he noted. Janis said the tipping point to change the way stroke research occurred across the country came about in a couple of different ways. First, stroke experts identified key research priorities during a NINDS strategic planning meeting two years ago and stressed the need for an orchestrated effort. Second, Janis said NINDS already had honed their ability to manage a coordinated effort through SPOTRIAS (Specialized Programs of Translational Research in Acute Stroke)."The idea behind the network is to take what we already know how to do and do it in a more efficient way," Janis said. NINDS has a long history of overseeing successful stroke clinical trials, including the first treatment for acute stroke, announced in 1995. Although sometimes slow, research translated from bench to bedside still has been so successful that mortality rates from stroke have declined significantly over the past decade. While still a leading cause of disability, stroke recently moved from the third leading cause of death in the United States to the fourth. Janis noted funding still would be available to researchers outside the network when appropriate. However, he added, the goal would be to collaborate with the network and to coordinate trials through the new mechanisms now in place."We want to be able to use this infrastructure we're investing in to be our frontline sites for stroke trials," he stated. In the Southeast, lead research sites include Emory University School of Medicine in Atlanta, Medical University of South Carolina in Charleston, Miller School of Medicine at the University of Miami, and Vanderbilt University Medical Center in Nashville. Providers and researchers can learn more about the network and clinical trials through the new website at nihstrokenet.org.
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