Acute Working Group Meeting (2nd & 4th Monday)

Registration is now open for the NINDS-sponsored 1.5 day conference entitled: Advancing the Study of Stroke in Women Through the Integration of Basic, Clinical and Socioeconomic Perspectives. WHEN: All day Monday, April 8, 2024 starting at 8:00 am (breakfast 7:30 am) and half day Tuesday, April 9th, 2024, starting at 7:45 am (breakfast 7:15) and ending at Noon WHERE: Sheraton Pentagon City, Arlington, VA (reduced rate of $199 + $28 taxes = $227 per night) CONFERENCE COST: $225 Use the links below for conference registration and hotel reservations.

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: For more information click 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.