Clinical trials of neurointervention : 2007-2018

J Neurointerv Surg. 2019 Dec;11(12):1277-1282. doi: 10.1136/neurintsurg-2019-015117. Epub 2019 Sep 17.

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.

Keywords: aneurysm; intervention; standards; statistics; stroke.

Publication types

  • Review

MeSH terms

  • Clinical Trials as Topic / methods*
  • Databases, Factual / trends*
  • Humans
  • Nervous System Diseases / surgery
  • Neurosurgical Procedures / methods*
  • Registries*
  • Research Design
  • Research Report
  • Vascular Surgical Procedures / methods*