@article{61ee89459a214ea8a7489520d6e72c6b,
title = "Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP Panel: Clinical trial inclusion/exclusion criteria and ethics",
abstract = "The International Campaign for Cures of Spinal Cord Injury Paralysis established a panel tasked with reviewing the methodology for clinical trials for spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the third of four papers. It examines inclusion and exclusion criteria that can influence the design and analysis of clinical trials in SCI, together with confounding variables and ethical considerations. Inclusion and exclusion criteria for clinical trials should consider several factors. Among these are (1) the enrollment of subjects at appropriate stages after SCI, where there is supporting data from animal models or previous human studies; (2) the severity, level, type, or size of the cord injury, which can influence spontaneous recovery rate and likelihood that an experimental treatment will clinically benefit the subject; and (3) the confounding effects of various independent variables such as pre-existing or concomitant medical conditions, other medications, surgical interventions, and rehabilitation regimens. An issue of substantial importance in the design of clinical trials for SCI is the inclusion of blinded assessments and sham surgery controls: every effort should be made to address these major issues prospectively and carefully, if clear and objective information is to be gained from a clinical trial. The highest ethical standards must be respected in the performance of clinical trials, including the adequacy and clarity of informed consent.",
keywords = "Clinical assessment, Clinical trial, Confounding variables, Ethics, Exclusion criteria, Inclusion criteria, Informed consent, Spinal cord injury",
author = "Tuszynski, {M. H.} and Steeves, {J. D.} and Fawcett, {J. W.} and D. Lammertse and M. Kalichman and C. Rask and A. Curt and Ditunno, {J. F.} and Fehlings, {M. G.} and Guest, {J. D.} and Ellaway, {P. H.} and N. Kleitman and Bartlett, {P. F.} and Blight, {A. R.} and V. Dietz and Dobkin, {B. H.} and R. Grossman and A. Privat",
note = "Funding Information: 1Department of Neurosciences, Center for Neural Repair, University of California,-San Diego, La Jolla, CA, USA; 2Department of Neurology, Veterans Administration Medical Center, La Jolla, CA, USA; 3ICORD, University of British Columbia and Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada; 4Cambridge University Centre for Brain Repair, Robinson Way, Cambridge, UK; 5Craig Hospital, Englewood, CO, USA; 6Department of Physical Medicine and Rehabilitation, University of Colorado at Denver and Health Sciences Center, Denver, CO, USA; 7Research Ethics Program and Department of Pathology, University of California - San Diego, La Jolla, CA, USA; 8Institute for OneWorld Health, San Francisco, CA, USA; 9Department of Rehabilitation Medicine, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA; 10Department of Surgery, University of Toronto, Division of Neurosurgery, Toronto, Ontario, Canada; 11Department of Neurosurgery, University of Miami, Miami, FL, USA; 12Department of Movement & Balance, Division of Neuroscience & Mental Health, Imperial College London, London , UK; 13National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA; 14National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA; 15Acorda Therapeutics, Inc., Hawthorne, New York, NY, USA; 16Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland; 17Department of Neurology, University of California Los Angeles, Geffen School of Medicine, Neurologic Rehabilitation and Research Program, Los Angeles, CA, USA; 18Methodist Neurological Institute, Houston, TX, USA; 19Institut des Neurosciences - CHU St Eloi, INSERM U-583, Montpellier Cedex, France Funding Information: This is the third paper of a series of four, reporting the deliberations of a panel sponsored by the International Campaign for Cures of spinal cord injury Paralysis (ICCP), an affiliation of {\textquoteleft}not for profit{\textquoteright} organizations, one of whose missions is to facilitate the translation of valid treatments for spinal cord injury (SCI) paralysis. Copyright: Copyright 2008 Elsevier B.V., All rights reserved.",
year = "2007",
month = mar,
day = "30",
doi = "10.1038/sj.sc.3102009",
language = "English (US)",
volume = "45",
pages = "222--231",
journal = "Spinal Cord",
issn = "1362-4393",
publisher = "Nature Publishing Group",
number = "3",
}