The US National Institutes of Health (NIH) has set up a network of regional stroke centres to streamline research and clinical trials in the field.
The NIH Stroke Trials Network, or NIH StrokeNet, will be funded and managed by the National Institute of Neurological Disorders and Stroke (NINDS), which has been conducting clinical trials for stroke over the last 40 years.
Working with nearby satellite facilities, the 25 regional stroke centres selected for the network span the US and include teams of researchers representing every medical speciality in stroke care, such as emergency medicine, neurosurgery, interventional neuroradiology, vascular neurology, neurointensive care, neuroimaging, stroke rehabilitation and peadiatric neurology.
Centralising approval
While addressing the three prongs of stroke research – prevention, treatment and recovery – NIH StrokeNet is also designed to streamline the research process by centralising the approval and review of clinical trials and assembling a comprehensive data-sharing system.
Each centre in the network will get five years’ funding, including US$200,000 in research costs and US$50,000 for training clinical researchers per year over the first three years. Additional funds will be milestone-related.
The University of Cincinnati will manage a national clinical co-ordinating centre for NIH StrokeNet, which will oversee and co-ordinate an institutional review board and master trial agreements for all the regional strokes centres. Next February, NIH will award the contract for a related national data-management centre.
In collaboration with the broader stroke community, NIH StrokeNet investigators will propose, develop and conduct trial protocols to be administered within the network, as well as training a future generation of clinical researchers in stroke.
Successful applicants for the network demonstrated experience in stroke research and recruitment, including the ability to enrol under-represented populations. They also had to offer access to the full cadre of specialties involved in stroke care.
Old model
Historically, the NIH explained, the model for stroke clinical trials in the US was to establish large teams of personnel and infrastructure, which were then dismantled once the study was completed.
This led to delays in patient recruitment and additional costs when new trials were initiated. Some clinical trials for stroke were lasting several years longer than expected and were costing millions of dollars more than the original estimate, the NIH said.
The network concept evolved from an NINDS planning effort, in which stroke experts were asked what was most needed to reduce death and disability from stroke in the US.
These experts called for a nationwide stroke network that would enable a more seamless transition between early safety and efficacy trials, and Phase II and III clinical studies.
Major challenge
The goal for NIH StrokeNet is to start four to five NINDS-funded exploratory Phase I and II clinical trials in stroke, as well as 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,” commented Scott Janis, NINDS programme director for the NIH Stroke Trials Network.
