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

Ansaar T. Rai, Thabele M. Leslie-Mazwi, Kyle M. Fargen, Aditya S. Pandey, Guilherme Dabus, Ameer E. Hassan, Justin F. Fraser, Joshua A. Hirsch, Rishi Gupta, Ricardo Hanel, Albert J. Yoo, Hormozd Bozorgchami, David Fiorella, J. Mocco, Adam S. Arthur, Osama Zaidat, Adnan H. Siddiqui

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)831-835
Number of pages5
JournalJournal of neurointerventional surgery
Volume12
Issue number9
DOIs
StatePublished - Sep 1 2020

Keywords

  • aneurysm
  • standards
  • stroke

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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