The Challenge and Opportunity of Clinical Investigation in SCI

While there is a desperate need for effective treatments for acute spinal cord injury (SCI), the research that has led to improvements in clinical practice over the past decade has relied more commonly on cohort and observational studies and not necessarily on large scale prospective randomized clinical trials.   In fact, the conduct of randomized clinical trials and the analysis of their data has contributed substantially to confusion among clinical care providers.

The clinical validation of novel therapeutic interventions is severely hampered by the need to recruit relatively large numbers of patients into clinical trials for sufficient statistical power.   The number of acute SCI patients who are eligible for acute neuroprotective trials can be as low as 16% of the total population of acute injuries presenting to any one centre.   The processes of ethics review boards and privacy legislation make recruitment of patients in their acute stages of injury exceedingly complex.

What is needed to enhance our fundamental understanding of the patho-anatomy and physiology of the injury, possible repair and regeneration processes, and the influence of various therapeutic initiatives are large scale international observational trials.  These trials will require common and coordinated data definitions, centralized data management, analyses, statistics, and a level of expertise in data linking and health informatics.   Engagement of clinical scientists with expertise in the core research methodologies used in these sorts of analyses will be critical.   Furthermore, to ensure that health system resources are used in a sustainable fashion, cost-effectiveness analysis must be integrated into the generation of evidence to identify and further best practice.

Spinal Cord Injury is an ideal specific disease entity on which to model this kind of integrated observational data network since the patients are generally highly motivated, they are cognitively intact, the injury is discrete, and the outcomes of repair and regeneration are objective and measurable.   The work of the Rick Hansen Spinal Cord Injury Registry will be used as an example of how a network of Spinal Cord Injury treatment centres can be engaged in providing prospective population based data on acute patients through their in-hospital care and through the process of re-integration into their communities.