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Clinical Neurology
Original research
Clinical trials of neurointervention : 2007–2018
  1. Hamidreza Saber1,
  2. Ashutosh P Jadhav2,
  3. Gary B Rajah3,
  4. Sandra Narayanan4,
  5. Sunil A Sheth5,
  6. David S Liebeskind6,
  7. Melek Somai7
  1. 1 Neurology, University of California Los Angeles, Los Angeles, California, USA
  2. 2 Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  3. 3 Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA
  4. 4 Departments of Neurosurgery and Neurology, Wayne State University School of Medicine, Detroit, Michigan, USA
  5. 5 Department of Neurology, University of Texas Health Science Center at Houston, Houston, Texas, USA
  6. 6 Department of Neurology, UCLA, Los Angeles, California, USA
  7. 7 Medicine, Medical College of Wisconsin, Milwaukee, WI, USA
  1. Correspondence to Dr Hamidreza Saber, Department of Neurology University of California Los Angeles Los Angeles California USA ; hsaber{at}mednet.ucla.edu

Abstract

Background ClinicalTrials.gov is one of the largest trials’ registries in the world.

Objective To leverage the ClinicalTrials.gov database to define the portfolio of clinical trials of neurointervention.

Methods We restricted our extraction to interventional clinical trials submitted between 2007 and 2018, and included MeSH terms that are part of the nervous system (n=19 344) or cardiovascular disease (n=19 234) categories and included a list of neurointerventional terms. The characteristics of trials, geographic distribution, dissemination, and funding sources were explored using descriptive and regression models.

Results A total of 206 neurointerventional clinical trials across 1691 medical centers were identified. Acute stroke was the most studied conditions (68, 33%), followed by aneurysms (63, 31%), carotid stenosis (48, 24%), intracranial atherosclerotic disease (7, 3.5%), cerebral venous thrombosis (6, 3%), arteriovenous malformation (4, 2%), idiopathic intracranial hypertension (3, 1.5%), and others (6, 3%). Overall, 59 (29%) trials were completed, 79 (37%) were active trials (28% recruiting), and 22 (11%) were terminated or suspended. Academic centers and industry were the most common primary funding source (63% and 29%, respectively), with no funding source reported in 16 (7.7%) trials. Among 77 completed or terminated trials, only 9 (11.7%) trials reported findings within 12 months. Median time to publication for trials funded by academia was 1.66 years (interquartile range (IQR) 0.7–2.1) versus 2.1 years (IQR 1.2–3.25) for industry-funded studies.

Conclusions A low dissemination rate for results and a high rate of study non-completion, as well as lack of geographic dispersion of trials appear to be major challenges in the field.

  • intervention
  • stroke
  • aneurysm
  • statistics
  • standards

https://doi.org/10.1136/neurintsurg-2019-015117

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    Footnotes

    • Contributors HS and MS participated in the conception and design of the study. HS and MS analyzed and interpreted the data. HS carried out the statistical analysis and wrote the article. AJ, GBR, SAS, SN, and DL revised the draft paper for intellectual content.

    • Funding Dr. Sheth reports funding from the American Academy ofNeurology/Society of Vascular and Interventional Neurology/American Brain Foundation (2018 Clinician-Scientist Development Award in Interventional Neurology). Other 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.

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

    • Patient consent for publication Not required.