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. 2020 Sep;12(9):831-835.
doi: 10.1136/neurintsurg-2020-016502. Epub 2020 Jun 30.

Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities

Ansaar T Rai  1 , Thabele M Leslie-Mazwi  2 , Kyle M Fargen  3 , Aditya S Pandey  4 , Guilherme Dabus  5 , Ameer E Hassan  6 , Justin F Fraser  7 , Joshua A Hirsch  8 , Rishi Gupta  9 , Ricardo Hanel  10 , Albert J Yoo  11 , Hormozd Bozorgchami  12 , David Fiorella  13 , J Mocco  14 , Adam S Arthur  15   16 , Osama Zaidat  17 , Adnan H Siddiqui  18
Affiliations

Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities

Ansaar T Rai et al. J Neurointerv Surg. 2020 Sep.

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.

Keywords: aneurysm; standards; stroke.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
(A) The randomized controlled trials (RCTs) and single arm studies for stroke and aneurysms being conducted at the responding sites (n=65) prior to COVID-19. (B) clinical trial suspension at the responding sites during the pandemic.
Figure 2
Figure 2
A chart of trial suspensions by state. The width of the bar for a given state correlates to the number of sites responding from that state. The wider the bar, the more the sites responding from that state. These are depicted in ascending order from left to right.
Figure 3
Figure 3
(A) Sites with partial or complete suspension (n=51) reporting endovascular treatment of patients with stroke or an aneurysm without enrollment. (B) Sites reporting missed clinical or imaging follow-up visits, protocol deviations, and loss of reimbursements. AIS, acute ischemic stroke.
Figure 4
Figure 4
Remote consent policies adopted at responding sites.
See this image and copyright information in PMC

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