Thenih strokenettrials implementation

Background and Aims: The NIH StrokeNet infrastructure, established in 2013, consists of theNational Coordinating Center at the University of Cincinnati that provides coordination of network activities;the National Data Management Center at the Medical University of South Carolina that coordinates centralized and standardized data collection, monitoring, and statistical support;27 Regional Coordinating Centers that manage 475 network sites;and the National Institute of Neurological Disorders and Stroke that provides administrative and scientific input. StrokeNet uses a central Institutional Review Board, and has a Training Core for educating and mentoring StrokeNet fellows. Methods: In the earlier years, StrokeNet's evolving trial submission and review process had been a high priority of network development. Attention is now focused on implementing trials that have been developed and funded through the review process. Results: There have been 119 concept proposals (Acute-46, Prevention-45, Recovery-28) submitted, 42 have been approved for scientific review with 48 feasibility assessments done by site survey prior to submission. The first StrokeNet trial, DEFUSE 3, recruited ahead of projection and was halted early for overwhelming efficacy. TeleRehabilitation met recruitment projections and finished on schedule. ARCADIA, MOST, Sleep SMART, TRANSPORT2, I-ACQUIRE, ARCADIA-CSI, SATURN, and ASPIRE trials are currently enrolling. FASTEST will start enrolling by the end of July 2021. COVID-19 required shutting down the network for 55 days in 2020. Trial protocol modifications and the addition of remote consenting and eConsent were instituted to resume enrollments safely. Conclusions: NIH StrokeNet has demonstrated the ability to implement innovative and impactful trials and respond to unprecedented events such as COVID-19.