SCOPE Goals 2008

1. Based upon the review of SCI Measures, completed through the ASIA-ISCoS-NIDRR partnership meetings held in 2006 and 2007, complete the development of summary papers on the more promising measurement techniques for the many different clinical targets after SCI (e.g. autonomic, sensory, motor, activities of daily living, quality of life).

2. Use the recently published guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel and available from www.nature.com/sc as a starting point for the continued development of clinical trial protocols, including

SCOPE Goals

a. different types of SCI or variations of experimental treatment (to demonstrate robustness of the initial finding)

b. different species (to demonstrate the fundamental nature of the therapeutic target and/or intervention

c. utilize the most clinically appropriate type of SCI injury to mimic the human condition (demonstrates relevance)

d. outline the safety and toxicological requirements (including pharmacodynamics and pharmacokinetics) that need to be satisfied by a pre-clinical discovery

e. disseminate the findings to all stakeholders for their input, revision, and adoption

3. Develop a conceptual discussion paper for all stakeholders on the validation and translation of a scientific discovery or therapeutic intervention to human study

a. further development of appropriate clinical trial outcome tools for different types of SCI, different times after SCI, and different phases of clinical trials

b. identification of functionally beneficial (clinical) endpoints

c. development of cogent inclusion and exclusion criteria for SCI trials with different clinical targets

d. detection of confounding factors that would alter the accurate interpretation of trial findings

e. dissemination of the findings to all stakeholders for their input, revision, and adoption

Spinal Cord Outcomes Partnership Endeavor