Pitt Named One of 25 Stroke Centers To Form New Nationwide Network

The National Institutes of Health (NIH) has named the University of Pittsburgh one of 25 stroke centers, located in selected regions, that will establish a new national network of health providers. The NIH StrokeNet will be dedicated to stroke prevention, treatment, and recovery. The goal of the nationwide network is to foster a more efficient and comprehensive process for testing research protocols and medical advances.

“This network represents a new and innovative approach to finding more effective methods to prevent and treat strokes,” said Lawrence Wechsler, professor and chair of the Department of Neurology in the University of Pittsburgh School of Medicine. “We are excited to be a part of the network and to bring these studies to the Pittsburgh area.”

Pitt, in coordination with the UPMC Stroke Institute, is the only Western Pennsylvania site in the network, which has centers strategically placed across the country. To qualify, Pitt demonstrated experience in stroke research and recruitment, including the ability to enroll underrepresented populations and to offer access to the full cadre of specialties involved in stroke care. These include: emergency medicine, neurosurgery, interventional neuroradiology, vascular neurology, neurointensive care, neuroimaging, stroke rehabilitation, and pediatric neurology.

Historically, the model for stroke clinical trials was to create large teams of personnel and infrastructure, which were then disassembled once the trial was completed. This model 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 originally estimated.

The network concept evolved from a National Institute of Neurological Disorders and Stroke 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.

In a Phase I clinical trial, researchers test a new drug or treatment in a small group of people to evaluate its safety, determine a safe dosage, and identify side effects. Phase II trials continue that evaluation on a larger group of people. Phase III trials involve giving the drug or treatment to large groups of people to confirm its effectiveness, monitor side effects, and compare it to commonly used treatments.

The National Institute of Neurological Disorders and Stroke has a strong history of successful stroke clinical trials over the past 40 years. Its research has lead to some significant advances in treatment and prevention, including the first treatment for acute stroke, announced in 1995.

“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, the associate director for clinical research at the National Institute of Neurological Disorders and Stroke, which will fund and manage the NIH Stroke Trials Network, or NIH StrokeNet.

Scott Janis, the National Institute of Neurological Disorders and Stroke program director of the NIH StrokeNet, said the institute has set a goal for the stroke network to initiate four to five institute-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,” he said. 

NIH StrokeNet investigators, working with the broader stroke community, will propose, develop, and conduct stroke protocols to be administered within the network and will train the future generation of clinical researchers in stroke.

Each stroke center will receive five-year funding, with $200,000 for research costs and $50,000 for training stroke clinical researchers paid per year over the first three years. Additional funds will be driven by the completion of milestones.

“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, deputy director of National Institute of Neurological Disorders and Stroke. “We need to have a balance of approaches to decrease the burden of illness due to stroke.”