Spinal cord injury research has matured to the extent that clinical trials are being held, or planned, for a number of very promising therapeutic approaches. This is a new era for the field, moving from research to application. But any form of this so-called translational research requires a coordinated approach to the process, from preclinical data assessment and trial protocols to actual treatment and outcome measures.
To assess the state of the translational efforts to date, the Journal of Neurosurgery: Spine has dedicated an entire issue to recent clinical trial developments in the field of SCI. The single-focus supplement (available free online) on the activities of the Reeve Foundation's North American Clinical Trials Network (NACTN). Any promising therapy must be proven effective, which requires a framework for studying large numbers of patients with SCI. That’s where NACTN comes in, to provide expertise, infrastructure, and efficiency to run trials and to evaluate their results.
NACTN, created in 2004, is a consortium of university hospital neurosurgical and neurorehabilitation teams to bring promising therapies into clinical trials by clinical collaboration among a global network of scientists. NACTN's lead investigator, neurosurgeon Robert G. Grossman, (Methodist Hospital, Houston), explains that given the complexity of SCI and the exorbitant cost of mounting clinical trials, "There can be no progress without partnerships, without collaborations, without alliance-building. Spinal cord injury is too difficult and too expensive to go-it-alone and there is no room for failure due to ill-conceived planning or lack of cutting-edge spinal cord expertise."
There are many challenges -- organizational, regulatory, and financial -- inherent in developing and conducting clinical trials; these challenges, said Dr. Grossman, often slow the process. "The complexity in organizing, planning, and initiating multicenter clinical trials, the prolonged time required for harmonization of protocols at multiple sites, and the cost of supporting the sizable teams needed to maintain the quality of measurement, data collection, and analysis are major factors in the slow pace of translating basic discoveries in the biology of repair of the injured spinal cord into clinical practice. The NACTN approach will minimize delay."
The journal supplement comprises 17 articles and several editorials. It is an academic collaboration between the journal and AOSpine North America -- this is an international community of spine and orthopedic surgeons, neurosurgeons, academics, and other spine care professionals dedicated to improving patient care and outcome. The supplement was directed by Michael Fehlings, Professor of Neurosurgery at the University of Toronto and Medical Director of the Krembil Neuroscience Centre at the Toronto Western Hospital.
The supplement includes papers related to identifying and evaluating different types of spinal cord trauma, including a characterization of the incidence and severity of acute complications after SCI, based on the NACTN prospective database. The NACTN decision making process for choosing therapeutics to study is evaluated.
Read the press release.