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.
journal_name
Spinal Cordjournal_title
Spinal cordauthors
Lammertse D,Tuszynski MH,Steeves JD,Curt A,Fawcett JW,Rask C,Ditunno JF,Fehlings MG,Guest JD,Ellaway PH,Kleitman N,Blight AR,Dobkin BH,Grossman R,Katoh H,Privat A,Kalichman M,International Campaign for Cures of Spinal Cdoi
10.1038/sj.sc.3102010subject
Has Abstractpub_date
2007-03-01 00:00:00pages
232-42issue
3eissn
1362-4393issn
1476-5624pii
3102010journal_volume
45pub_type
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