Spinal cord research is at a critical crossroads. Dozens of promising therapies aimed at regenerating function are in the pipeline, and moving them into clinical use is the highest priority. Yet, despite the increasing traffic on the path to clinical progress, the roadway is still largely under construction. A number of fundamental scientific questions remain unanswered, both about the immense natural variability of spinal cord injury and how best to measure therapeutic efficacy. Such questions require large studies, involving multiple centers using the same examination criteria and treatment protocols. Toward that end, the Foundation has brought together five leading clinical research centers and a biostatistical center to create the CRF North American Clinical Trials Network for the Treatment of Spinal Cord Injury. By its nature, spinal cord injury presents special challenges to therapeutic development. The treatment strategies currently under development target individual steps along the pathway to recovery, from limiting secondary inflammation immediately after an injury, to preventing scar formation and stimulating axons to re-grow, to using stem cells to replace dead or damaged nerve cells. Outcome measures that are currently used in evaluating these interventions are somewhat crude and not likely to pick up the small changes that are expected when these techniques are initially used. To ensure that clinical studies assess the appropriate factors in a way that is statistically meaningful, the Network investigators are working on defining the variables and measures of progress that will enable multiple analyses of the data set - including everything from age and injury particulars, to the nature and timing of post-injury interventions, to results of diagnostic studies. It is hoped that the establishment of the Network will lay a common framework for clinical trial design and analysis that can be used by researchers worldwide. By forging links with similar-minded groups in other countries, it will also provide an opportunity for researchers and clinicians in different countries to communicate and collaborate.
The mission of the North American Clinical Trials Network for the Treatment of Spinal Cord Injury is to bring promising therapies out of the laboratory and into clinical trials, in a manner that provides incontrovertible evidence of effectiveness and safety. The North American group will collaborate with a similar network in Europe to define the natural history of spinal cord injury and develop measures for assessing treatment success. It is hoped that this collaboration will provide the foundation for a global network that will speed therapeutic development and ensure that powerful new therapies will be made available to those in need. NACTN will also work closely with the CRF Individual Research Consortium on Spinal Cord Injury to ensure an ongoing dialogue between laboratory researchers and clinicians. Through workshops and other educational programs, Consortium scientists will have the opportunity to network with clinical specialists from North America and Europe, facilitating educational exchanges and iterative discussions about Consortium research.
The CRF North American Clinical Trials Network is based at six sites in the U.S. and Canada. Five of the centers focus on clinical investigations while the sixth is responsible for data analysis and management.
Northwestern University, Rehabilitation Institute of Chicago, IL University of Texas Health Science Center, Houston, TX University of Toronto, Toronto, ON University of Virginia, Charlotesville, VA University of Texas School of Public Health, Houston, TX
Clinical Trials in Spinal Cord Injury: Other Resources With spinal cord clinical trials already underway in the U.S. and many more to come in the next few years, there is an urgent need to build bridges among researchers and pave the way for accelerated progress. These websites provide up-to-date information on current trials, discussion-based workshops, and other initiatives that seek to define guidelines and standards. About Clinical Trials Report of the International Clinical Trials Workshop on Spinal Cord Injury: click here to download the PDF or view the report in your browser ClinicalTrials.gov: http://clinicaltrials.gov/ct/gui/c/b NIH Roadmap: http://nihroadmap.nih.gov NINDS Workshop: Translating Promising Strategies for Spinal Cord Injury Therapy: http://www.ninds.nih.gov/news_and_events/proceedings/sci_translation_workshop.htm
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