Characteristics of completed clinical trials for spinal cord injury from 1999 to 2020

Chiduziem Onyedimma, F. M. Moinuddin, Yagiz U. Yolcu, Allie J. Canoy lllies, Sally El Sammak, Brandon C. Trammell, Christine L. Hunt, Wenchun Qu, Mohamad Bydon

Research output: Contribution to journalArticlepeer-review

Abstract

Numerous clinical trials are being conducted in the field of spinal cord injury (SCI). These trials are typically registered on ClinicalTrials.gov. The objective of this study was to identify the characteristics of the completed SCI trials and characterize the potential factors associated with publication. ClinicalTrials.gov database was queried for all the completed trials on patients with SCI. Baseline characteristics of the completed trials were assessed. The publication status of these trials was identified using PubMed or Google Scholar. The secondary and primary outcomes reported in the publication were then compared to the outcomes registered in ClinicalTrial.gov. Multivariable logistic regression analysis was performed to determine the characteristics associated with publication status and time to publication. A total of 457 of 1,061 trials on SCI were completed. Of those, 60% were ultimately published. Trials that had received funding from sources besides the NIH, private industries, or the federal government were more likely to remain unpublished. The median time to publish was three years, with larger trials taking a longer time. The median sample size for completed trials was 30. Assessment of mismatch rates in primary outcomes of published data to registered outcomes was 8.9%. In SCI trials, outcomes registered on ClinicalTrial.gov often matched published results. Additionally, sample size and funding source play a significant role in the publication rate of these trials. Published data represents a reliable source for clinicians, researchers, and patients; efforts to curb publication bias and reporting bias are paramount for implementing evidence-based practices and ensure proper scientific conduct.

Original languageEnglish (US)
Pages (from-to)114-119
Number of pages6
JournalJournal of Clinical Neuroscience
Volume94
DOIs
StatePublished - Dec 2021

Keywords

  • Clinical trials
  • Clinicaltrials.gov
  • SCI
  • Spinal cord injury
  • Trial registration

ASJC Scopus subject areas

  • Surgery
  • Neurology
  • Clinical Neurology
  • Physiology (medical)

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