The University of Texas Health Science Center at Houston is part of a nationwide effort by the National Institutes of Health (NIH) to establish a network of regional stroke centers across the country. UTHealth is one of only 25 regional centers participating in the new “NIH StrokeNet” program, and the only one representing the state of Texas.
Giuseppe N. Colasurdo, M.D., president of UTHealth, commented on the significance of UTHealth being named a part of the elite NIH initiative on stroke: “That UTHealth is the only center with this designation in the state and region, speaks to our track record of delivering the highest quality care and our long-standing tradition of being one of the best stroke centers in the nation.”
UTHealth was chosen by the National Institute of Neurological Disorders and Stroke (NINDS), the funding and management arm of the NIH for this project, due to its demonstrated and proven prowess in stroke research and recruitment due to the institution’s ability to enroll underrepresented populations as well as its comprehensive stroke research, prevention, treatment, and recovery services, including emergency medicine, neurosurgery, interventional neuroradiology, vascular neurology, neurointensive care, neuroimaging, stroke rehabilitation and pediatric neurology.
Moreover, UTHealth and Memorial Hermann-Texas Medical Center was the only research center among the six original institutions chosen for NIH StrokeNet who have successfully tested tissue plasminogen activator (tPA), the only known stroke treatment. In addition, researchers at UTHealth are currently testing add-on medications to tPA. BioNews Texas covered this story back in July, when science columnist Ayesha Khan reported on UTHealth’s testing of CLOTBUST-ER Ultrasound in Combination With tPA As Therapy For Stroke.
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The idea behind NIH StrokeNet is to consolidate research and treatment efforts for stroke in an organized network that spans the entire nation, giving patients access to advanced care, and researchers a network of shared data and finding on three key areas of research: prevention, treatment and recovery. As part of this network, UTHealth will contribute some of its top researchers in the field of stroke prevention and treatment, including Sean I. Savitz, M.D., the Frank M. Yatsu, M.D., Chair in Neurology, who will serve as principal investigator. Both The University of Texas Health Science Center at San Antonio and Tulane University School of Medicine will participate as satellite research hubs for UTHealth in its new projects, helping to cover the large geographic expanse of the Gulf region. It is expected that more research institutions in the region will also join the effort as well.
The new NIH StrokeNet project is being funded and managed by NINDS bringing to bear its proven history of successful stroke clinical trials over the past 40 years, which has led to some of the most successful stroke treatment developments in the history of modern medicine, including the first treatment for acute stroke, announced in 1995. The NINDS will provide $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 award of a national data management center for the project has yet to be announced, though the NIH intends to do so in February of 2014.
The data center will be the final lynchpin in the program, which is designed to dramatically facilitate what stroke researchers have consistently 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. Because the traditional model for stroke clinical trials has been inefficient at best, there have been major 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. If stroke-related clinical trials can be centrally managed and administrated, improved coordination can mean improved data and lower costs.
Together with an overarching plan to propose, develop and conduct stroke protocols to be administered within the network and train the future generation of clinical researchers in stroke, StrokeNet promises to help revolutionize the stroke research effort on a national level, and fundamentally accelerate research and development of treatments.
“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).
Scott Janis, Ph.D., NINDS program director of the NIH StrokeNet, has laid out an audacious plan that will rapidly accelerate stroke-related clinical trials: “Our goal for the NIH Stroke Centers Network is to initiate four to five NINDS-funded exploratory Phase I and II stroke clinical trials, and two to four Phase III trials over the next five years. This is a major challenge which we believe the stroke research community will embrace.”
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