News Release

Thursday, December 12, 2013

NIH network revolutionizes stroke clinical research

Stroke remains number one cause of disability and fourth leading cause of death in the United States.

A network of 25 regional stroke centers working with nearby satellite facilities will span the country, have teams of researchers representing every medical specialty needed for stroke care and will address the three prongs of stroke research: prevention, treatment and recovery. 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.

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.”

“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.

NIH StrokeNet

• NIH StrokeNet Clinical Coordinating Center
  University of Cincinnati
  PI: Joseph Broderick
  Media Contact:
  Keith Harrell
  513-558-4559
• NIH StrokeNet Centers
  Case Western University, Cleveland
  PI: Anthony Furlan
  PI: Peter Rasmussen
  Media Contact:
  Amanda Petrak
  216-368-0345
• Emory University School of Medicine, Atlanta
  PI: Michael Frankel
  Media Contact:
  Robin Reese
  404-727-9371
• Massachusetts General Hospital/Partners HealthCare, Boston
  PI: Lee Schwamm
  Media Contact:
  Mike Morrison
  617-724-6425
• Medical University of South Carolina, Charleston
  PI: Edward Jauch
  Media Contact:
  Heather Woolwine
  843-792-7669
• MedStar Health Research Institute, MedStar NRH, Georgetown University, Washington, D.C.
  PI: Alex Dromerick
  MedStar Health Research Institute, MedStar Washington Hospital Center, Washington, D.C.
  PI: Amie Hsia
  Media Contact:
  Derek Berry
  202-877-1773
• The New York City Collaborative Regional Coordinating Center
  PI: Stanley Tuhrim
  PI: Laura Balcer
  PI: Bernadette Boden-Albala
  PI: Mark Mehler
  Media Contact:
  Sid Dinsay
  212-241-9200
• New York – Presbyterian/Columbia University Medical Center New York - and Weill Cornell Medical College
  PI: Randy Marshall
  Media Contacts:
  Karin Eskenazi (Columbia)
  212-342-0508
  Christina Stolfo (NY Presbyterian)
  212-821-0560
  Jennifer Gundersen (Cornell)
  646-317-7401
• Northwestern University at Chicago
  PI: Shyam Prabhakaran
  Media Contact:
  Kris Lathan
  312-926-2963
• The Ohio State University Wexner Medical Center, Columbus
  PI: Michel Torbey
  Media Contact:
  Eileen Scahill
  614-293-3737
• Stanford University, Palo Alto, Calif.
  PI: Greg Albers
  Media Contact:
  Ruthann Richter
  650-725-8047
• University of California, Los Angeles
  PI: Jeff Saver
  PI: Gene Sung
  Media Contact:
  Mark Wheeler
  310-794-2265
• University of California, San Diego
  PI: Brett Meyer
  Media Contact:
  Jackie Carr
  619-543-6202
• University of California, San Francisco
  PI: Wade Smith
  Media Contact:
  Peter Farley
  415-502-6397
• University of Cincinnati
  PI: Pooja Khatri
  PI: Dawn Kleindorfer
  Media Contact:
  Keith Harrell
  513-558-4559
• University of Iowa, Iowa City
  PI: Enrique Leira
  Media Contact:
  Thomas Moore
  319-356-3945
• University of Miami Miller School of Medicine
  PI: Jose Romano
  PI: Ralph Sacco
  Media Contact:
  Lisa Worley
  305-243-5184
• University of Michigan Health System, Ann Arbor
  PI: Phillip Scott
  PI: Devin Brown
  Media Contact:
  Kara Gavin
  734-764-2220
• University of Minnesota, Minneapolis
  PI: Mustapha Ezzeddine
  Media Contact:
  Matt Point
  612-625-4110
• University of Pennsylvania, Philadelphia
  PI: Scott Kasner
  Media Contact:
  Kim Menard
  215-662-6183
• University of Pittsburgh
  PI: Lawrence Wechsler
  Media Contact:
  Cristina Mestre
  412-586-9776
• The University of Texas Health Science Center at Houston
  PI: Sean Savitz
  Media Contact:
  Deborah Lake
  713-500-3304
• University of Utah, Salt Lake City
  PI: Jennifer Majersik
  Media Contacts:
  Kathy Wilets
  Paul Gadd
  801-581-5717
• UW Medicine, University of Washington, Seattle
  PI: David Tirschwell
  Media Contact:
  Leila Gray
  206-685-0381
• University of Wisconsin, Madison
  PI: Robert Dempsey
  Media Contact:
  Susan Hilts Smith
  608-279-2272
• Vanderbilt University Medical Center, Nashville, Tenn.
  PI: Howard Kirshner
  PI: J Mocco
  Media Contact:
  Craig Boerner
  615-322-4777

For more information about stroke, please visit: http://stroke.nih.gov.

NINDS is the nation’s leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world.

The study was funded by the following NINDS grants: (centers) 1U10NS086497-01; 1U10NS086489-01; 1U10NS086513-01; 1U10NS086729-011U10NS086512-01; 1U10NS086607-01; 1U10NS086492-01; 1U10NS086467-01; 1U10NS086494-01; 1U10NS086608-01; 1U10NS086484-01; 1U10NS086728-01; 1U10NS086521-01; 1U10NS086606-01; 1U10NS086496-01; 1U10NS086526-01; 1U10NS086487-01; 1U10NS086535-01; 1U10NS086474-01; 1U10NS086528-01; 1U10NS086531-01; 1U10NS086533-01; 1U10NS086490-01; 1U10NS086525-01; (clinical coordinating center) 1U01 NS086872-01.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health^®

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