title: Clinical trials in spinal cord injury.
abstract: Progress in promoting axonal plasticity and regeneration in animal models of spinal cord injury (SCI) has led to novel prospects for the initiation of human clinical trials in the near future. This review discusses a number of considerations in the path to translating a preclinical candidate from the laboratory to clinical testing. We will also briefly discuss issues associated with the design, performance, analysis, and reporting of human clinical trials in SCI. It is important, for both the medical community and the spinal cord injured community, that objective scientific and medical standards are adopted in the clinical translation of potentially promising, but as yet unproven, therapies for SCI.
authors.affiliation: Acorda Therapeutics, Hawthorne, New York, USA.
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Blight
authors.forename: Mark H
authors.initials: MH
authors.lastname: Tuszynski
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards; D023381:Endpoint Determination; D006801:Humans; D011446:Prospective Studies; D013119:Spinal Cord Injuries / Q000503:physiopathology / Q000628:therapy*