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J Neurotrauma. 2017 Feb;34(3):599-606. doi: 10.1089/neu.2016.4568. Epub 2016 Oct 24.

Predicting Recruitment Feasibility for Acute Spinal Cord Injury Clinical Trials in Canada Using National Registry Data.

Author information

1
1 Division of Neurosurgery, Dalhousie University , Halifax, Nova Scotia, Canada .
2
2 Rick Hansen Institute , Vancouver, British Columbia, Canada .
3
3 Western University , London, Ontario, Canada .
4
4 The Ottawa Hospital, Ottawa Hospital Research Institute, University of Ottawa , Ottawa, Ontario, Canada .
5
5 Hamilton General, McMaster University , Hamilton, Ontario, Canada .
6
6 University of British Columbia , Vancouver, British Columbia, Canada .
7
7 Division of Neurosurgery and Spinal Program, University of Toronto , Toronto, Ontario, Canada .
8
8 Blusson Spinal Cord Centre , Vancouver, British Columbia, Canada .

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.

KEYWORDS:

clinical trial; feasibility studies; registries; research methodology; spinal cord injury

PMID:
27627704
DOI:
10.1089/neu.2016.4568
[Indexed for MEDLINE]

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