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Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities
  1. Ansaar T Rai1,
  2. Thabele M Leslie-Mazwi2,
  3. Kyle M Fargen3,
  4. Aditya S Pandey4,
  5. Guilherme Dabus5,
  6. Ameer E Hassan6,
  7. Justin F Fraser7,
  8. Joshua A Hirsch8,
  9. Rishi Gupta9,
  10. Ricardo Hanel10,
  11. Albert J Yoo11,
  12. Hormozd Bozorgchami12,
  13. David Fiorella13,
  14. J Mocco14,
  15. Adam S Arthur15,16,
  16. Osama Zaidat17,
  17. Adnan H Siddiqui18
  1. 1 Interventional Neuroradiology, West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, USA
  2. 2 Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts, USA
  3. 3 Department of Neurological Surgery and Radiology, Wake Forest University, Winston-Salem, North Carolina, USA
  4. 4 Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan, USA
  5. 5 Department of Interventional Neuroradiology and Neuroendovascular Surgery, Miami Neuroscience Institute and Miami Cardiac & Vascular Institute - Baptist Hospital, Miami, Florida, USA
  6. 6 Department of Neurology, University of Texas Rio Grande Valley School of Medicine, Edinburg, Texas, USA
  7. 7 Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA
  8. 8 NeuroEndovascular Program, Massachusetts General Hospital, Boston, Massachusetts, USA
  9. 9 Department of Neurosurgery, WellStar Health System, Marietta, Georgia, USA
  10. 10 Stroke and Cerebrovascular Center, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA
  11. 11 Department of Neurointervention, Texas Stroke Institute, Plano, Texas, USA
  12. 12 Oregon Health and Science University, Portland, Oregon, USA
  13. 13 Department of Neurosurgery, Stony Brook University, Stony Brook, New York, USA
  14. 14 The Mount Sinai Health System, New York, New York, USA
  15. 15 Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA
  16. 16 Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA
  17. 17 Department of Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA
  18. 18 Department of Neurosurgery, Gates Vascular Institute at Kaleida Health, Buffalo, New York, USA
  1. Correspondence to Dr Ansaar T Rai, Department of Interventional Neuroradiology, West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, USA; ansaar.rai{at}gmail.com

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.

  • standards
  • stroke
  • aneurysm
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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http://dx.doi.org/10.1136/neurintsurg-2020-016502

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    Footnotes

    • Twitter @Ansaar_Rai, @JoshuaAHirsch, @AdamArthurMD

    • Correction notice This article has been corrected since it was published Online First. The title was updated from 'Neuroendovascular clinical trials disruptions due to COVID-19 potential future challenges and opportunities' to 'Neuroendovascular Clinical Trials Disruptions Due To COVID-19. Potential Future Challenges and Opportunities'

    • Contributors ATR, AHS, ASP, AEH, GD, OZ, AJY, ASA, JM, and DF contributed to the study design. ATR, TML-M, KMF, ASP, AEH, GD, and JFF contributed to manuscript preparation. Everyone contributed to data collection and gave input into the study design and manuscript preparation.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data sharing not applicable as no datasets generated and/or analysed for this study. No data are available.

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    © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.