RT Journal Article
SR Electronic
T1 Clinical trials of neurointervention : 2007–2018
JF Journal of NeuroInterventional Surgery
JO J NeuroIntervent Surg
FD BMJ Publishing Group Ltd.
SP 1277
OP 1282
DO 10.1136/neurintsurg-2019-015117
VO 11
IS 12
A1 Hamidreza Saber
A1 Ashutosh P Jadhav
A1 Gary B Rajah
A1 Sandra Narayanan
A1 Sunil A Sheth
A1 David S Liebeskind
A1 Melek Somai
YR 2019
UL http://jnis.bmj.com/content/11/12/1277.abstract
AB 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.