NIH has created the NIH StrokeNet to conduct small and large clinical trials and research studies to advance acute stroke treatment, stroke prevention, and recovery and rehabilitation following a stroke across the lifespan. This network of 27 regional centers across the U.S., which involves approximately 500 hospitals in the U.S., is designed to serve as the infrastructure and pipeline for exciting new potential treatments for patients with stroke and those at risk for stroke. The StrokeNet trials also collaborate with sites in other countries including Canada, Germany, United Kingdom, Spain, and Japan. In addition, NIH StrokeNet will provide an educational platform for stroke physicians, clinical trial coordinators and stroke researchers.
NINDS established the NIH StrokeNet to facilitate the development, promotion and conduct of high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment and recovery. An additional goal of the StrokeNet is to educate future stroke investigators and researchers in stroke prevention, treatment and recovery. The educational core provides webinars focused on stroke, research methodology and professional development. This network currently has a network of 27 regional coordinating centers, involves approximately 500 hospitals across the United States and is designed to serve as the infrastructure and pipeline for new potential treatments for patients with stroke and those at risk of stroke.
We are pleased to announce the continuation of the NINDS Clinical Trials Methodology Course (CTMC). We are currently accepting applications for the 2024 cohort. The overarching goal of the CTMC is to help investigators develop scientifically rigorous, yet practical clinical trial protocols. Our focus is on investigators who have not previously designed their own prospective, interventional clinical trials. Applicants proposing large, multi-center trials will also be considered this year. The multi-center proposals should ideally be aligned with the focus areas of one of the established NINDS clinical research networks.
Steven M. Greenberg, Wendy C. Ziai, Charlotte Cordonnier, Dar Dowlatshahi, Brandon Francis, Joshua N. Goldstein, J. Claude Hemphill III, Ronda Johnson, Kiffon M. Keigher, William J. Mack,
J. Mocco, Eileena J. Newton, Ilana M. Ruff, Lauren H. Sansing, Sam Schulman, Magdy H. Selim,
Kevin N. Sheth, Nikola Sprigg, Katharina S. Sunnerhagen, and on behalf of the American Heart Association/American Stroke Association, Published May 17, 2022
Ashkan Shoamanesh, Magdy Selim, Published June 6, 2022
Kevin N. Sheth, MD, Magdy Selim, MD, PhD, Published June 27, 2022
The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United
States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. F DA is committed to providing timely guidance to support continuity and response efforts to this pandemic.
FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.
The primary concern for StrokeNet is the safety of our patients or potential patients for our ongoing trials. The second concern is the safety of our own investigators and study team members. Finally, we also want to maintain, as much as possible, the integrity of the trials to potentially benefit patients and so that the data can be used to answer the questions that the trials intended. This latter point is critical for subjects in the trial and those with the specific problem in the future.
However, immediate safety issues take priority over any formal processes in ongoing trials. For example, while a current protocol may specify that a study visit needs to be in person, the FDA has guidance about the primary safety of study subjects:
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The National Institute of Neurological Disorders and Stroke (NINDS), and National Institutes of Health (NIH) recently assembled an external working group of international experts to update the Stroke v1.0 Common Data Elements (CDEs) based on user feedback and research advances.
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NIH StrokeNet Education “Pathophysiological Links between Migraine and Stroke”; Presented by Cenk Ayata, MD, Harvard Medical School, Massachusetts General Hospital NIH StrokeNet Education “Pathophysiological Links between Migraine and Stroke”; Presented by Cenk Ayata, MD, Harvard Medical School, Massachusetts General HospitalNIH StrokeNet Education “Pathophysiological Links between Migraine and Stroke.
Treatments for acute stroke include IV t-PA, stroke centers, stroke units, endovascular thrombectomy devices for selected patients, nimodipine for subarachnoid hemorrhage, and aneurysm coiling and clipping for ruptured aneurysms. Intracerebral hemorrhage has proven to be the most challenging for effective treatments; however recent research has shown promise
Despite the advances made in acute stroke care, stroke remains the leading cause of adult disability in Americans. World-wide there is an estimated 50 million stroke survivors coping with significant physical, cognitive and emotional deficits. The field of stroke recovery and restorative neuroscience is still young and provides a rich environment for innovative trials.