title: Cross-sectional analysis of data from the U.S. clinical trials database reveals poor translational clinical trial effort for traumatic brain injury, compared with stroke.
abstract: Traumatic brain injury (TBI) is an important public health problem, comparable to stroke in incidence and prevalence. Few interventions have proven efficacy in TBI, and clinical trials are, therefore, necessary to advance management in TBI. We describe the current clinical trial landscape in traumatic brain injury and compare it with the trial efforts for stroke. For this, we analysed all stroke and TBI studies registered on the US Clinical Trials (www.clinicaltrials.gov) database over a 10-year period (01/01/2000 to 01/31/2013). This methodology has been previously used to analyse clinical trial efforts in other specialties. We describe the research profile in each area: total number of studies, total number of participants and change in number of research studies over time. We also analysed key study characteristics, such as enrolment number and scope of recruitment. We found a mismatch between relative public health burden and relative research effort in each disease. Despite TBI having comparable prevalence and higher incidence than stroke, it has around one fifth of the number of clinical trials and participant recruitment. Both stroke and TBI have experienced an increase in the number of studies over the examined time period, but the rate of growth for TBI is one third that for stroke. Small-scale (<1000 participants per trial) and single centre studies form the majority of clinical trials in both stroke and TBI, with TBI having significantly fewer studies with international recruitment. We discuss the consequences of these findings and how the situation might be improved. A sustained research effort, entailing increased international collaboration and rethinking the methodology of running clinical trials, is required in order to improve outcomes after traumatic brain injury.
authors.affiliation: Division of Medicine, Imperial College London, London, United Kingdom.
authors.forename: Lucia M
authors.initials: LM
authors.lastname: Li
authors.affiliation: Division of Anaesthesia, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
authors.forename: David K
authors.initials: DK
authors.lastname: Menon
authors.affiliation: Department of Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
authors.forename: Tobias
authors.initials: T
authors.lastname: Janowitz
mesh_terms: D000328:Adult; D017677:Age Distribution; D001930:Brain Injuries / Q000453:epidemiology*; D002648:Child; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003430:Cross-Sectional Studies; D016208:Databases, Factual; D006801:Humans; D020521:Stroke / Q000453:epidemiology*; D057170:Translational Research, Biomedical / Q000706:statistics & numerical data*; D014481:United States