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.
authors.affiliation: Department of Neurosciences, Center for Neural Repair, University of California-San Diego, La Jolla 92093, CA, USA.
authors.forename: M H
authors.initials: MH
authors.lastname: Tuszynski
authors.forename: J D
authors.initials: JD
authors.lastname: Steeves
authors.forename: J W
authors.initials: JW
authors.lastname: Fawcett
authors.forename: D
authors.initials: D
authors.lastname: Lammertse
authors.forename: M
authors.initials: M
authors.lastname: Kalichman
authors.forename: C
authors.initials: C
authors.lastname: Rask
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authors.lastname: Curt
authors.forename: J F
authors.initials: JF
authors.lastname: Ditunno
authors.forename: M G
authors.initials: MG
authors.lastname: Fehlings
authors.forename: J D
authors.initials: JD
authors.lastname: Guest
authors.forename: P H
authors.initials: PH
authors.lastname: Ellaway
authors.forename: N
authors.initials: N
authors.lastname: Kleitman
authors.forename: P F
authors.initials: PF
authors.lastname: Bartlett
authors.forename: A R
authors.initials: AR
authors.lastname: Blight
authors.forename: V
authors.initials: V
authors.lastname: Dietz
authors.forename: B H
authors.initials: BH
authors.lastname: Dobkin
authors.forename: R
authors.initials: R
authors.lastname: Grossman
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authors.initials: A
authors.lastname: Privat
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000592:standards*; D006801:Humans; D018579:Patient Selection / Q000941:ethics*; D012107:Research Design / Q000592:standards*; D013119:Spinal Cord Injuries / Q000628:therapy*