The long-term objective of the Network of Excellence in Neuroscience Clinical Trials (NEXT) initiative is to rapidly and efficiently translate advances n 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 f 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 of the 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 clinica 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 trials.
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 professiona mentorship.
Specific Aim 3 is to engage and mobilize federal, industry, foundation 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 trial 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.
|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|
|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|
|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|
|Kaufmann, Petra; O'Rourke, P Pearl (2015) Central institutional review board review for an academic trial network. Acad Med 90:321-3|
|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|
|Gutmann, Laurie; Shy, Michael (2015) Update on Charcot-Marie-Tooth disease. Curr Opin Neurol 28:462-7|
|Kolb, Stephen J (2013) NeuroNEXT SMA biomarkers study. Ann Neurol 74:A8|