title: Opinions on the preclinical evaluation of novel therapies for spinal cord injury: a comparison between researchers and spinal cord-injured individuals.
abstract: We previously conducted a survey to gather the opinions and perspectives of scientific and clinical researchers on what levels of preclinical evidence were needed to justify translating a promising neuroprotective or neuroregenerative therapy in spinal cord injury (SCI) into a human clinical trial (Kwon et al., 2010 ). Here we conducted an analogous survey of individuals living with SCI in which we gathered their expectations for the levels of preclinical evidence achieved by researchers in substantiating the neuroprotective and neuroregenerative therapies being offered to them in clinical trials. In total, 214 individuals with SCI completed the survey, and their responses were compared to the responses of the 235 scientists and clinicians who completed our previous survey. SCI individuals were more likely than SCI researchers to opine that demonstrating efficacy and safety in rodent models of SCI alone is sufficient to proceed with clinical trials. However, SCI individuals also reported strong support for large animal and primate model studies, and in the case of the latter, were actually more in agreement for the need for primate studies than researchers. SCI individuals also reported strong support for independent replication studies. In general, individuals with SCI had high expectations for the levels of preclinical evidence required to justify translating novel therapies into clinical trials. These expectations should be considered in the decisions to translate specific experimental therapies for SCI.
authors: Combined Neurosurgical and Orthopaedic Spine Program, Department of Orthopaedics, University of British Columbia, British Columbia, Canada. brian.kwon@vch.ca
authors: Brian K
authors: BK
authors: Kwon
authors: Arvindera
authors: A
authors: Ghag
authors: Leilani
authors: L
authors: Reichl
authors: Marcel F
authors: MF
authors: Dvorak
authors: Judy
authors: J
authors: Illes
authors: Wolfram
authors: W
authors: Tetzlaff
mesh_terms: D000328:Adult; D000818:Animals; D001291:Attitude of Health Personnel; D001294:Attitude to Health; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D010342:Patient Acceptance of Health Care / Q000523:psychology*; D012108:Research Personnel / Q000592:standards / Q000639:trends; D013119:Spinal Cord Injuries / Q000503:physiopathology / Q000628:therapy*; D057170:Translational Research, Biomedical / Q000592:standards*