A Grading System to Evaluate Pre-Clinical Data of Clinical Translation for SCI


The history of human translation of experimental therapies in SCI has not been very long, nor has it witnessed the successes that can guide the translation of other therapies. In the future, the demonstration of an efficacious treatment for human SCI will be extremely helpful, as it may provide some guidance regarding which pre-clinical steps are most important. Such a demonstration will likely also change how we view certain aspects of pre-clinical evidence, and in turn require recalibration of the scoring system. Until that happens, we are dependent upon the perspectives and opinions of the members of our scientific community. The subscores that were selected (animal species, injury paradigms, time window, demonstration of clinically meaningful efficacy, and reproducibility) were based upon the questionnaire results. How they are scored and weighted could certainly be the subject of further debate, but we felt that the experience of the attendees of the focus-group meeting were extremely helpful in providing an expert opinion that could guide this process. This represents a first attempt to provide a structure for how to assess objectively the body of pre-clinical evidence for a potentially “promising” SCI therapy. We acknowledge that it is an imperfect, unproven system, and the methodology of its establishment – while systematic – is somewhat removed from a formal Delphi process. Nonetheless, we feel that it does capture the perspectives of a large body of SCI researchers, in addition to the opinion of a panel of recognized SCI experts. We will welcome further dialogue on this important issue and encourage further improvements and refinements of this grading system, given the compelling need to establish truly effective therapies for individuals who suffer this injury.

(continued abstract and discussions):

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3143387/?tool=pubmed

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