The long-term objective ofthe Network of Excellence in Neuroscience Clinical Trials (NEXT) initiative is to rapidly and efficiently translate advances in neuroscience into treatments for people with neurological disorders. Acute and chronic neurological disorders impose a massive burden on both patients and society. The potential exists to change this situation if recent major discoveries in basic neuroscience can be exploited effectively. Challenges to the successful and efficient development of treatments for people with neurological disorders include inefficiencies in regulatory and institutional approvals; a variety of barriers to recruitment of subjects that slow down clinical research and a shortage of individuals trained and prepared to lead multicenter clinical research. The primary goal ofthe Clinical Coordinating Center (NEXT-CCC) is to facilitate, from initial conception through final analysis, clinical trials in adult and pediatric neurological disorders by providing efficient methodological, organizational and logistical support. The NEXT-CCC will establish processes that will dramatically increase the efficiency of multicenter clinical trials, improve the quality of clinical trials promote patient recruitment and retention and increase the number of clinical investigators and research staff who are well trained and passionate about leading and conducting multicenter clinical trails.
Specific aim 1 is to create a collaborative Clinical Coordinating Center and network infrastructure to efficiently conduct high quality clinical trials for neurological disorders in both adult and pediatric populations.
Specific aim 2 is to expand the pool of experienced clinical Investigators and research staff who are prepared to be leaders of multicenter clinical research trials by providing education, training, resources and professional mentorship.
Specific aim 3 is to engage and mobilize federal, industry, foundations and patient partners by working with the Steering Committee, NEXT-DCC, and Project Team Principal Investigators to organize high impact clinical trials for neurological disorders through the network.
Despite advances in understanding the causes of several neurological disorders, many remain without meaningful treatment options. The creation of an efficient CCC with a central IRB, master tnal agreement, and rigorous and innovative processes to design, implement and report clinical trials will expedite translation of breakthroughs in understanding disease processes into treatments for people with neurological disorders.
| Fox, Robert J; Coffey, Christopher S; Conwit, Robin et al. (2018) Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis. N Engl J Med 379:846-855 |
| Bartlett, Amy; Kolb, Stephen J; Kingsley, Allison et al. (2018) Recruitment & retention program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA! Contemp Clin Trials Commun 11:113-119 |
| Kolb, Stephen J; Coffey, Christopher S; Yankey, Jon W et al. (2017) Natural history of infantile-onset spinal muscular atrophy. Ann Neurol 82:883-891 |
| Kolb, Stephen J; Coffey, Christopher S; Yankey, Jon W et al. (2016) Baseline results of the NeuroNEXT spinal muscular atrophy infant biomarker study. Ann Clin Transl Neurol 3:132-45 |
| Lyden, Patrick; Weymer, Sara; Coffey, Chris et al. (2016) Selecting Patients for Intra-Arterial Therapy in the Context of a Clinical Trial for Neuroprotection. Stroke 47:2979-2985 |
| Fox, Robert J; Coffey, Christopher S; Cudkowicz, Merit E et al. (2016) Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis. Contemp Clin Trials 50:166-77 |
| O'Rourke, P Pearl; Carrithers, Judith; Patrick-Lake, Bray et al. (2015) Harmonization and streamlining of research oversight for pragmatic clinical trials. Clin Trials 12:449-56 |
| Kaufmann, Petra; O'Rourke, P Pearl (2015) Central institutional review board review for an academic trial network. Acad Med 90:321-3 |
| Gutmann, Laurie; Shy, Michael (2015) Update on Charcot-Marie-Tooth disease. Curr Opin Neurol 28:462-7 |
| Klein, Max M; Treister, Roi; Raij, Tommi et al. (2015) Transcranial magnetic stimulation of the brain: guidelines for pain treatment research. Pain 156:1601-14 |
Showing the most recent 10 out of 11 publications
