North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury: A Consortium of Military, Veterans Administration and Civilian Hospitals.

摘要

Five hundred twenty-four acutely injured patients have been enrolled in the NACTN data registry as of 12/31/2011 and enrollment continues at the clinical centers. Thirty-six acutely injured patients were enrolled in the Riluzole Phase I safety study. Data analyses are ongoing and a decision to move forward to a Phase 2 efficacy study will be made when analysis is complete. NACTN has become a resource for the spinal cord injury field at large and is approached now by academic labs, biotech and pharma industries seeking guidance and collaboration; the network has several therapies under consideration for trialing, in addition to Riluzole. NACTN operates under formally adopted Governance Policies & Procedures (revised effective 11-2011) and works through established committees. Oversight for all NACTN operations is vested in its Executive Committee. Under the aegis of its Neurological Outcomes Committee (NOA), five contracts have been issued to develop and finalize new outcome instruments. A book chapter on NACTN is in press; a complications manuscript has been revised and submitted to Journal of Neurotrauma; in collaboration with AO Spine NA, NACTN PIs have written a series of papers that will be published (Summer 2012) in a J Neurosurgery-Spine supplement issue on SCI that is featuring the work of NACTN. NACTN is collaborating with the European EM-SCI and the North American STASCIS networks on a series of research questions involving discrete merged data. In addition, under the aegis of the AO Spine Knowledge Forum, NACTN is exploring a complete merge of international registries, including EM-SCI, STASCIS and Rick Hansen. Lastly, effective 1/1/2012, SAMMC will join NACTN as the second military hospital; given its catchment area and patient population, it is expected to be a prolific contributor to NACTN studies.