1. ¹Craig Hospital, Englewood, CO, USA
2. ²Department of Physical Medicine and Rehabilitation, University of Colorado at Denver and Health Sciences Center, Denver, CO, USA
3. ³Center for Neural Repair, Department of Neurosciences, University of California – San Diego, La Jolla, CA, USA
4. ⁴Department of Neurology, Veterans Administration Medical Center, La Jolla, CA, USA
5. ⁵ICORD, University of British Columbia and Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada
6. ⁶Cambridge University Centre for Brain Repair, Cambridge, UK
7. ⁷Institute for OneWorld Health, San Francisco, CA, USA
8. ⁸Department of Rehabilitation Medicine, Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA
9. ⁹Department of Surgery, Division of Neurosurgery, University of Toronto, Toronto, Ontario, Canada
10. ¹⁰University of Miami, Department of Neurosurgery, Miami, FL, USA
11. ¹¹Department of Movement & Balance, Division of Neuroscience & Mental Health, Imperial College London, Charing Cross Campus, London, UK
12. ¹²National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA
13. ¹³Acorda Therapeutics Inc., Hawthorne, NY, USA
14. ¹⁴Department of Neurology, University of California at Los Angeles, Los Angeles, CA, USA
15. ¹⁵Methodist Neurological Institute, Houston, TX, USA
16. ¹⁶Keio University School of Medicine, Tokyo, Japan
17. ¹⁷Institut des Neurosciences – CHU St Eloi, INSERM U-583, Montpellier cedex, France
18. ¹⁸Research Ethics Program, Department of Pathology, University of California at San Diego, La Jolla, CA, USA

Correspondence: D Lammertse, Craig Hospital, 3425 S. Clarkson Street, Englewood, Colorado, 80113, USA

Abstract

The International Campaign for Cures of Spinal Cord Injury Paralysis established a panel tasked with reviewing the methodology for clinical trials for spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the fourth of four papers. Here, we examine the phases of a clinical trial program, the elements, types, and protocols for valid clinical trial design. The most rigorous and valid SCI clinical trial would be a prospective double-blind randomized control trial utilizing appropriate placebo control subjects. However, in specific situations, it is recognized that other trial procedures may have to be considered. We review the strengths and limitations of the various types of clinical trials with specific reference to SCI. It is imperative that the design and conduct of SCI clinical trials should meet appropriate standards of scientific inquiry to insure that meaningful conclusions about efficacy and safety can be achieved and that the interests of trial subjects are protected. We propose these clinical trials guidelines for use by the SCI clinical research community.