Your browser doesn't support javascript.
Neuroendovascular clinical trials disruptions due to COVID-19. Potential future challenges and opportunities.
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.
  • Rai AT; Interventional Neuroradiology, West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, USA ansaar.rai@gmail.com.
  • Leslie-Mazwi TM; Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Fargen KM; Department of Neurological Surgery and Radiology, Wake Forest University, Winston-Salem, North Carolina, USA.
  • Pandey AS; Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan, USA.
  • Dabus G; Department of Interventional Neuroradiology and Neuroendovascular Surgery, Miami Neuroscience Institute and Miami Cardiac & Vascular Institute - Baptist Hospital, Miami, Florida, USA.
  • Hassan AE; Department of Neurology, University of Texas Rio Grande Valley School of Medicine, Edinburg, Texas, USA.
  • Fraser JF; Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
  • Hirsch JA; NeuroEndovascular Program, Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Gupta R; Department of Neurosurgery, WellStar Health System, Marietta, Georgia, USA.
  • Hanel R; Stroke and Cerebrovascular Center, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA.
  • Yoo AJ; Department of Neurointervention, Texas Stroke Institute, Plano, Texas, USA.
  • Bozorgchami H; Oregon Health and Science University, Portland, Oregon, USA.
  • Fiorella D; Department of Neurosurgery, Stony Brook University, Stony Brook, New York, USA.
  • Mocco J; The Mount Sinai Health System, New York, New York, USA.
  • Arthur AS; Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA.
  • Zaidat O; Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
  • Siddiqui AH; Department of Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA.
J Neurointerv Surg ; 12(9): 831-835, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-626369
Semantic information from SemMedBD (by NLM)
1. Acute Cerebrovascular Accidents PROCESS_OF Patients
Subject
Acute Cerebrovascular Accidents
Predicate
PROCESS_OF
Object
Patients
2. Acute Cerebrovascular Accidents PROCESS_OF Patients
Subject
Acute Cerebrovascular Accidents
Predicate
PROCESS_OF
Object
Patients
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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Randomized Controlled Trials as Topic / Brain Ischemia / Surveys and Questionnaires / Coronavirus Infections / Stroke / Betacoronavirus Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Prognostic study / Randomized controlled trials Limits: Female / Humans / Male Language: English Journal: J Neurointerv Surg Year: 2020 Document Type: Article Affiliation country: Neurintsurg-2020-016502

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Randomized Controlled Trials as Topic / Brain Ischemia / Surveys and Questionnaires / Coronavirus Infections / Stroke / Betacoronavirus Type of study: Controlled clinical trial / Diagnostic study / Clinical Practice Guide / Prognostic study / Randomized controlled trials Limits: Female / Humans / Male Language: English Journal: J Neurointerv Surg Year: 2020 Document Type: Article Affiliation country: Neurintsurg-2020-016502