title: Bench to bedside: challenges of clinical translation.
abstract: Translating a scientific discovery from the laboratory to human application involves a series of challenges. Each requirement must be satisfactorily answered before moving to the next phase. Initially, there are several issues associated with the reproducibility of the original discovery. Subsequently, additional preclinical aspects of safety, formulation, dose, administration route, timing of delivery, and pharmacokinetics must be completed before entering human trials. Central nervous system disorders, such as spinal cord injury (SCI), are heterogeneous. The level and severity of SCI impacts the functional capacity of an individual and their prognosis for recovery. Thus, the selection and stratification of appropriate participants, as well as the choice of an appropriate outcome measure, should be based on prior analysis and modeling of the natural history for both neurological impairment and activities of daily living. A great deal of wisdom can be gathered from historical datasets to assure that a clinical trial program has the best study protocol to clearly detect any potential therapeutic benefit.
authors.affiliation: ICORD (International Collaboration On Repair Discoveries), Blusson Spinal Cord Centre, Vancouver General Hospital, University of British Columbia (UBC), Vancouver, BC, Canada. Electronic address: steeves@icord.org.
authors.forename: John D
authors.initials: JD
authors.lastname: Steeves
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D006801:Humans; D013119:Spinal Cord Injuries / Q000628:therapy*; D057170:Translational Research, Biomedical
keywords: clinical trial protocols; outcome measures; participant selection; preclinical validation; spinal cord injury; therapeutic development