title: Predicting Recruitment Feasibility for Acute Spinal Cord Injury Clinical Trials in Canada Using National Registry Data.
abstract: Traumatic spinal cord injury (SCI) represents a significant burden of illness, but it is relatively uncommon and heterogeneous, making it challenging to achieve sufficient subject enrollment in clinical trials of therapeutic interventions for acute SCI. The Rick Hansen Spinal Cord Injury Registry (RHSCIR) is a national SCI Registry that enters patients with SCI from acute-care centers across Canada. To predict the feasibility of conducting clinical trials of acute SCI within Canada, we have applied the inclusion/exclusion criteria of six previously conducted SCI trials to the RHSCIR data set and generated estimates of how many Canadian persons would have been eligible theoretically for enrollment in these studies. Data for SCI cases were prospectively collected for RHSCIR at 18 acute and 13 rehabilitation sites across Canada. RHSCIR patients enrolled between 2009-2013 who met the following key criteria were included: non-penetrating traumatic SCI; received acute care at a RHSCIR site; age more than 18, less than 75 years, and had complete admission single neurological level of injury data. Inclusion and exclusion criteria for the Minocycline in Acute Spinal Cord injury (Minocycline), Riluzole, Surgical Timing in Acute Spinal Cord Injury Study (STASCIS), Cethrin, Nogo antibody study (NOGO), and Sygen studies were applied retrospectively to this data set. The numbers of patients eligible for each clinical trial were determined. There were 2166 of the initial 2714 patients (79.8%) who met the key criteria and were included in the data set. Projected annual numbers of eligible patients for each trial were: Minocycline, 117; Riluzole, 62; STASCIS, 109; Cethrin, 101; NOGO, 82; and Sygen, 70. An additional 8.0% of the sample had a major head injury (Glasgow Coma Scale [GCS] score ≤12) and would have been excluded from the trials. RHSCIR provides a comprehensive national data set that may serve as a useful tool in the planning of multicenter clinical SCI trials.
authors.affiliation: 1 Division of Neurosurgery, Dalhousie University , Halifax, Nova Scotia, Canada .
authors.forename: Ginette
authors.initials: G
authors.lastname: Thibault-Halman
authors.affiliation: 2 Rick Hansen Institute , Vancouver, British Columbia, Canada .
authors.forename: Carly S
authors.initials: CS
authors.lastname: Rivers
authors.affiliation: 3 Western University , London, Ontario, Canada .
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Bailey
authors.affiliation: 4 The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa , Ottawa, Ontario, Canada .
authors.forename: Eve C
authors.initials: EC
authors.lastname: Tsai
authors.affiliation: 5 Hamilton General, McMaster University , Hamilton, Ontario, Canada .
authors.forename: Brian
authors.initials: B
authors.lastname: Drew
authors.affiliation: 2 Rick Hansen Institute , Vancouver, British Columbia, Canada .|6 University of British Columbia , Vancouver, British Columbia, Canada .
authors.forename: Vanessa K
authors.initials: VK
authors.lastname: Noonan
authors.affiliation: 7 Division of Neurosurgery and Spinal Program, University of Toronto , Toronto, Ontario, Canada .
authors.forename: Michael G
authors.initials: MG
authors.lastname: Fehlings
authors.affiliation: 8 Blusson Spinal Cord Centre , Vancouver, British Columbia, Canada .
authors.forename: Marcel F
authors.initials: MF
authors.lastname: Dvorak
authors.affiliation: 2 Rick Hansen Institute , Vancouver, British Columbia, Canada .
authors.forename: Dilinuer
authors.initials: D
authors.lastname: Kuerban
authors.affiliation: 8 Blusson Spinal Cord Centre , Vancouver, British Columbia, Canada .
authors.forename: Brian K
authors.initials: BK
authors.lastname: Kwon
authors.affiliation: 1 Division of Neurosurgery, Dalhousie University , Halifax, Nova Scotia, Canada .
authors.forename: Sean D
authors.initials: SD
authors.lastname: Christie
mesh_terms: D000328:Adult; D000368:Aged; D002170:Canada / Q000453:epidemiology; D016208:Databases, Factual / Q000706:statistics & numerical data; D005240:Feasibility Studies; D005260:Female; D005544:Forecasting; D006801:Humans; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000627:therapeutic use; D018579:Patient Selection; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012042:Registries / Q000706:statistics & numerical data; D012189:Retrospective Studies; D019782:Riluzole / Q000627:therapeutic use; D013119:Spinal Cord Injuries / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D055815:Young Adult
chemical_list: D019782:Riluzole; D008911:Minocycline
keywords: clinical trial; feasibility studies; registries; research methodology; spinal cord injury