title: Clinical trials in mild traumatic brain injury.
abstract: Traumatic brain injury is an increasingly prevalent injury seen in both civilian and military populations. Regardless of the mechanisms of injury, the most common sub-type of injury continues to be mild traumatic brain injury. Within the last decade, there has been tremendous growth in the literature regarding this disease entity.
  
  
  
  To describe the obstacles necessary to overcome in performing a rigorous and sound clinical research study investigating mild traumatic brain injury. This examination begins by a consideration of changing standards for good faith open and total reporting of any and all conflicts of interest or commitment. This issue is particularly critical in mTBI research. We next examine obstacles that include but are not limited to diagnostic criteria, inclusion/exclusion criteria, source of injury, previous history of injury, presence of comorbid conditions and proper informed consent of participants. Frequently, multi-center studies are necessary for adequate subject accrual with the added challenges of site coordination, data core management and site specific study conduct. We propose a total reversal to the traditional translational research approach where clinical studies drive new concepts for future basic science studies.
  
  
  
  There have been few mild traumatic brain injury clinical trials in the literature with treatments/interventions that have been able to overcome many of these described obstacles. We look forward to the results of current and ongoing clinical mild traumatic brain injury studies providing the tools necessary for the next generation of basic science projects.
authors.affiliation: Department of Otolaryngology, University of Miami, Miller School of Medicine, United States; Department of Neurological Surgery, University of Miami, Miller School of Medicine, United States; University of Miami, Sports Performance and Wellness Institute, United States. Electronic address: Michael.hoffer@miami.edu.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Hoffer
authors.affiliation: Department of Otolaryngology, University of Miami, Miller School of Medicine, United States; University of Miami, Sports Performance and Wellness Institute, United States.
authors.forename: Mikhaylo
authors.initials: M
authors.lastname: Szczupak
authors.affiliation: Department of Otolaryngology, University of Pittsburgh, United States.
authors.forename: Carey
authors.initials: C
authors.lastname: Balaban
mesh_terms: D001924:Brain Concussion / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods; D016265:Conflict of Interest; D006801:Humans
keywords: Clinical trial; Mild traumatic brain injury; Neurosensory; Vestibular