Characteristics of completed clinical trials for spinal cord injury from 1999 to 2020 |
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| Affiliation: | 1. Mayo Clinic Neuro-Informatics Laboratory, Department of Neurological Surgery, Mayo Clinic, Rochester, MN, USA;2. Department of Neurological Surgery, Mayo Clinic, Rochester, MN, USA;3. Department of Pain Medicine, Mayo Clinic, Jacksonville, FL, USA;4. Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, FL, USA;1. Spine Research Group, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, USA;2. Department of Neurological Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, USA;3. Department of Orthopaedic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, USA;1. School of Medicine, University of Sinú, Cartagena, Colombia;2. School of Medicine, Rafael Núñez University Corporation, Cartagena, Colombia;3. Colombian Clinical Research Group in Neurocritical Care, School of Medicine, University of Cartagena, Cartagena, Colombia;4. Latin American Council of Neurocritical Care, Cartagena, Colombia;1. Centro Chirurgico Toscano, Arezzo, Italy;2. Department of Human Neurosciences, “Sapienza” University of Rome, Italy;1. Department of Neurology, Vanderbilt University Medical Center, 1211 Medical Center Dr, Nashville TN 37232, USA;3. Tulane University School of Medicine, 1430 Tulane Ave, New Orleans, LA 70112, USA;4. Department of Communication Science and Disorders, University of Pittsburgh School of Health and Rehabilitation Sciences, 5035 Forbes Tower, Pittsburgh, PA 15260, USA;5. Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, 1211 Medical Center Dr, Nashville, TN 37232, USA;1. Department of Pediatric Surgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China;2. Department of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China;1. Department of Neurosurgery, K.E.M. Hospital and Seth G.S. Medical College, Parel, Mumbai, India;2. Department of Neurosurgery, Lilavati Hospital and Research Centre, Bandra, Mumbai, India |
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| 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. |
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| Keywords: | Spinal cord injury SCI Clinicaltrials gov Clinical trials Trial registration |
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