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Michigan hospitals form network to help revolutionize stroke clinical research

One of 25 in nation funded by National Institutes of Health to tackle 4th leading cause of death and top cause of disability

ANN ARBOR, Mich. Nine hospitals in southeast Michigan have come together to form one of 25 regional stroke networks across the nation that will allow teams of researchers representing every medical specialty needed for stroke care to address the three prongs of stroke research: prevention, treatment and recovery.

The new Michigan StrokeNet and its counterpart networks were announced today by the National Institutes of Health. It is the only network in Michigan, and will seek to add additional Michigan hospitals over time.

Michigan StrokeNet will be coordinated by the University of Michigan Health System’s Stroke Program, and involves two U-M Health System hospitals, two from the Trinity Health system and five Detroit Medical Center hospitals. Philip Scott, M.D. and Devin Brown, M.D., of U-M’s Department of Emergency Medicine and Department of Neurology will serve as co-principal investigators.

Devin Brown, M.D. and Phillip Scott, M.D

“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 networks are strategically placed in every region of the country. All have 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. Each network will receive infrastructure funding for research and education support, with $50,000 per year allocated to train the next generation of  stroke clinical researchers.

U-M is already the home of the national clinical coordinating center of the NIH-funded Neurological Emergencies Treatment Trials network, which coordinates studies on the emergency care of a range of brain-related issues.

 The nine participants in Michigan StrokeNet are:

  • University Hospital (U-M Health System), Ann Arbor
  • Saint Joseph Mercy Health System, Ann Arbor
  • Saint Mary Mercy, Livonia
  • DMC Detroit Receiving Hospital, Detroit
  • DMC Sinai-Grace Hospital, Detroit
  • DMC Harper University Hospital, Detroit
  • DMC Rehabilitation Institute of Michigan, Detroit
  • DMC Children’s Hospital of Michigan, Detroit
  • C.S. Mott Children’s Hospital (U-M Health System), Ann Arbor

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. wrote:  “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.”

“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,” said Scott Janis, Ph.D., NINDS program director of the NIH StrokeNet.                

A stroke occurs when blood flow to the brain is interrupted, causing brain cells in the immediate area to die because they stop getting oxygen. Stroke can also occur when a vessel breaks and bleeds into the brain. The number of new strokes reported each year is 795,000, making stroke the fourth leading cause of death in the US. Because stroke is age-linked the incidence is expected to rise rapidly in the next decade. For more information about stroke, please visit: stroke.nih.gov.

For more information about stroke research and care at the U-M Health System, visit www.uofmhealth.org/medical-services/stroke

For more information about participating in clinical research studies at the University of Michigan Health System:  www.umclinicalstudies.org .

 

 

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