Opinions on the Preclinical Evaluation of Novel Therapies for Spinal Cord Injury Kwon BK, Ghag A, Reichl L, Dvorak MF, Illes J, Tetzlaff W.
Source: University of British Columbia, Dept. of Orthopaedics, Vancouver, British Columbia, Canada; firstname.lastname@example.org.
We previously conducted a survey to garner the opinions and perspectives of scientific and clinical researchers on what levels of preclinical evidence were needed in order to justify translating a promising neuroprotective or neuro-regenerative 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 spinal cord injury in which we garnered their expectations for the levels of preclinical evidence achieved by researchers in substantiating the neuroprotective and neuro-regenerative 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 a 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 spinal cord injury.
The comments posted below from some of the 235 researchers and clinicians are as interesting as the article itself in addition to the perspective of people with SCI.