The Network for Excellence in Neuroscience Clinical Trials (NEXT) is a new funding opportunity of the NIH/NINDS to establish a clinical research network to develop and conduct rigorous, scientifically-sound exploratory clinical trials for neurologic diseases that affect both adults and children. Biomarker identification and refinement is also a key goal of the network. NEXT's mission is to provide an infrastructure for the rapid development and implementation of protocols so that exploratory treatments can more quickly be tested in a multicenter framework. A federated IRB model and other forms of centralized administration are planned to facilitate and expedite regulatory approvals. NEXT will provide support for clinical site investigators and coordinators. The Department of Neurology and Neurotherapeutics and the Division of Pediatric Neurology at UT Southwestern Medical Center have extensive experience in multicenter clinical trials across a broad spectrum of neurological disorders. Dr. Gil Wolfe, who directs the adult neuromuscular division, and Dr. Susan Iannaccone, Chief of Pediatric Neurology with a longstanding interest in spinal muscular atrophy, have assembled clinical investigators in neurology and related disciplines and leveraged community resources to form the Improving Neuroscience Trials Enrollment in North Texas (INTENT). In addition, UT Southwestern has established a Department of Clinical Sciences supported by an NIH Clinical and Translational Science Award (CTSA) that provides a rich framework of support for clinical trials. The Department of Clinical Sciences partners with 13 institutions in North and Central Texas through the CTSA. As a result, links to UT Southwestern are already in place for cooperative efforts at the institutional level. In addition, neurology providers at UT Southwestern have developed strong referral patterns from the community for both common and rare diseases. Referral volumes are high and benefit from the fact that the Dallas-Fort Worth metropolitan area is the largest in the United States with a single allopathic medical school.
The NEXT award will enable the Department of Neurology and Division of Child Neurology at UT Southwestern to expeditiously test experimental therapies in both children and adults with neurological disorders through the INTENT network. The award will provide the large and growing multi-ethnic North and Central Texas population access to novel, promising treatment approaches for common and rare diseases.
| Gilbreath, Heather R; Castro, Diana; Iannaccone, Susan T (2014) Congenital myopathies and muscular dystrophies. Neurol Clin 32:689-703, viii |
