NIH Network Revolutionizes Stroke Clinical Research
News Dec 13, 2013
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.
Brain Regions Implicated in Mental Disorders Influenced by Neanderthal GenesNews
Findings indicate that the more a person’s genome carries genetic vestiges of Neanderthals, the more certain parts of his or her brain and skull resemble those of humans’ evolutionary cousins that went extinct 40,000 years ago.READ MORE
Ingestible Drug-Delivery Materials May Improve Patient Treatment ComplianceNews
Hydrogel-based capsules could expand and reside in the GI tract for days, slowly releasing medication.READ MORE
Waterlogged Brain Region Helps Scientists Gauge Damage Caused by Parkinson’s DiseaseNews
Development suggests that fluid changes in a specific brain area could provide a way to track that damage.READ MORE
Comments | 0 ADD COMMENT
International Conference and Exhibition on Nanomedicine and Nanotechnology
Nov 23 - Nov 24, 2017