The Neuro-EM Program is currently accepting applications for its inaugural scholar cohort as well as nominations for its Pipeline Program. Scholar applications and Pipeline nominations are due October 1, 2024. Click Full Story for more information Full story
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 Full story
Ashkan Shoamanesh, Magdy Selim, Published June 6, 2022 Full story
Kevin N. Sheth, MD, Magdy Selim, MD, PhD, Published June 27, 2022 Full story
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. Full story
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: For more information click Full Story: Full story
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. Full story