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 Christopher and Dana Reeve Foundation created the North American Clinical Trails Network (NACTN) in 2004. NACTN is a network of hospitals that is enrolling newly injured patients into a data registry, defining and adhering to standard protocols and providing the infrastructure and highly skilled personnel needed to conduct trials of therapy for spinal cord injury. Since fiscal year 2006, NACTN has been supported by both the Reeve Foundation and the US Army Medical Research and Material Command under Contract No. W81ZWH-07-1-0361. Department of Defense funding is enabling NACTN expansion into military and new civilian hospitals and eventually to VA hospitals as well. The rapidly expanding network will serve as the infrastructure for and have the capacity to conduct high-quality collaborative phase I and phase II - III randomized clinical trials with the statistical power to determine the effectiveness of emerging SCI therapies. 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 is collaborating with a similar network in Europe, and one just now forming in Canada, to define the natural history of spinal cord injury and develop measures for assessing treatment success. It is hoped that these collaborations 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 Reeve Foundation 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 across North America and Europe, facilitating educational exchanges and iterative discussions about the development of effective treatments for spinal cord injury. At the present time, the Reeve Foundation North American Clinical Trials Network is based at nine sites in the U.S. and Canada. Eight of the centers focus on clinical investigations while the ninth is responsible for data analysis and management. The Methodist Hospital, Houston, TX Northwestern University, Rehabilitation Institute of Chicago, IL University of Louisville, Louisville, KY University of Maryland Medical System, Baltimore, MD University of Texas Health Science Center, Houston, TX University of Toronto, Toronto, ON University of Virginia, Charlottesville, VA University of Texas School of Public Health, Houston, TX 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. ICCP Guidelines on Clinical Trials: The International Campaign for Cures of spinal cord injury Paralysis (of which the Reeve Foundation is a proud member) has created a guide to clinical trials suitable for non-medical professionals. This important document fully explains what clinical trials are and why they are so important in the development of new treatments for spinal cord injury. The guide advises readers on what to look for and which questions to ask when considering entering a clinical trial themselves, and also provides an easy-to-understand summary of the trials currently underway for emerging SCI treatments. To download the complete document, please click here. To download a shortened version of the document, please click here. About Clinical Trials: for information on SCI clinical trials in plain language appropriate for the layman, visit the research section of paralysis.org: http://www.paralysis.org/site/c.erJMJUOxFmH/b.1337933/k.9B0F/Clinical_Trials.htm 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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