Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities. (30th June 2020)

• Record Type: Journal Article
• Authors: Rai, Ansaar T; Leslie-Mazwi, Thabele M; Fargen, Kyle M; Pandey, Aditya S; Dabus, Guilherme; Hassan, Ameer E; Fraser, Justin F; Hirsch, Joshua A; Gupta, Rishi; Hanel, Ricardo; Yoo, Albert J; Bozorgchami, Hormozd; Fiorella, David; Mocco, J; Arthur, Adam S; Zaidat, Osama; Siddiqui, Adnan H
• Is Part Of: Journal of neurointerventional surgery. Volume 12:Number 9(2020)
• Page Start: 831
• Page End: 835
• Publication Date: 2020-06-30
• Subjects: standards -- stroke -- aneurysm; Nervous system -- Surgery -- Periodicals; Cerebrovascular disease -- Surgery -- Periodicals; 617.48
• DOI: 10.1136/neurintsurg-2020-016502
• Languages: English
• ISSNs: 1759-8478

Abstract

Abstract : To assess the impact of COVID-19 on neurovascular research and deal with the challenges imposed by the pandemic. Methods: A survey-based study focused on randomized controlled trials (RCTs) and single-arm studies for acute ischemic stroke and cerebral aneurysms was developed by a group of senior neurointerventionalists and sent to sites identified through the clinical trials website (https://clinicaltrials.gov/ ), study sponsors, and physician investigators. Results: The survey was sent to 101 institutions, with 65 responding (64%). Stroke RCTs were being conducted at 40 (62%) sites, aneurysm RCTs at 22 (34%) sites, stroke single-arm studies at 37 (57%) sites, and aneurysm single-arm studies at 43 (66%) sites. Following COVID-19, enrollment was suspended at 51 (78%) sites—completely at 21 (32%) and partially at 30 (46%) sites. Missed trial-related clinics and imaging follow-ups and protocol deviations were reported by 27 (42%), 24 (37%), and 27 (42%) sites, respectively. Negative reimbursements were reported at 17 (26%) sites. The majority of sites, 49 (75%), had put new trials on hold. Of the coordinators, 41 (63%) worked from home and 20 (31%) reported a personal financial impact. Remote consent was possible for some studies at 34 (52%) sites and for all studies at 5 (8%) sites. At sites with suspended trials (n=51), endovascular treatment without enrollment occurred at 31 (61%) sites for stroke and 23 (45%) sites for aneurysms. A total of 277 patients with acute ischemic stroke and 184 with cerebral aneurysms were treated without consideration for trial enrollment. Conclusion: Widespread disruption of neuroendovascular trials occurred because of COVID-19. As sites resume clinical research, steps to mitigate similar challenges in the future should be considered.