title: Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design.
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 fourth of four papers. Here, we examine the phases of a clinical trial program, the elements, types, and protocols for valid clinical trial design. The most rigorous and valid SCI clinical trial would be a prospective double-blind randomized control trial utilizing appropriate placebo control subjects. However, in specific situations, it is recognized that other trial procedures may have to be considered. We review the strengths and limitations of the various types of clinical trials with specific reference to SCI. It is imperative that the design and conduct of SCI clinical trials should meet appropriate standards of scientific inquiry to insure that meaningful conclusions about efficacy and safety can be achieved and that the interests of trial subjects are protected. We propose these clinical trials guidelines for use by the SCI clinical research community.
authors.affiliation: Craig Hospital, Englewood, CO 80113, USA.
authors.forename: D
authors.initials: D
authors.lastname: Lammertse
authors.forename: M H
authors.initials: MH
authors.lastname: Tuszynski
authors.forename: J D
authors.initials: JD
authors.lastname: Steeves
authors.forename: A
authors.initials: A
authors.lastname: Curt
authors.forename: J W
authors.initials: JW
authors.lastname: Fawcett
authors.forename: C
authors.initials: C
authors.lastname: Rask
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: A R
authors.initials: AR
authors.lastname: Blight
authors.forename: B H
authors.initials: BH
authors.lastname: Dobkin
authors.forename: R
authors.initials: R
authors.lastname: Grossman
authors.forename: H
authors.initials: H
authors.lastname: Katoh
authors.forename: A
authors.initials: A
authors.lastname: Privat
authors.forename: M
authors.initials: M
authors.lastname: Kalichman
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000592:standards; D012107:Research Design / Q000592:standards*; D013119:Spinal Cord Injuries / Q000628:therapy*