RT Journal Article
SR Electronic
T1 Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities
JF Journal of NeuroInterventional Surgery
JO J NeuroIntervent Surg
FD BMJ Publishing Group Ltd.
SP 831
OP 835
DO 10.1136/neurintsurg-2020-016502
VO 12
IS 9
A1 Ansaar T Rai
A1 Thabele M Leslie-Mazwi
A1 Kyle M Fargen
A1 Aditya S Pandey
A1 Guilherme Dabus
A1 Ameer E Hassan
A1 Justin F Fraser
A1 Joshua A Hirsch
A1 Rishi Gupta
A1 Ricardo Hanel
A1 Albert J Yoo
A1 Hormozd Bozorgchami
A1 David Fiorella
A1 J Mocco
A1 Adam S Arthur
A1 Osama Zaidat
A1 Adnan H Siddiqui
YR 2020
UL http://jnis.bmj.com/content/12/9/831.abstract
AB 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.