Network for Excellence in Neuroscience Clinical Trials, NeuroNEXT: Concept to Implementation (P04.245)

OBJECTIVE: NeuroNEXT was designed to expand NINDS9 capability to test promising new therapies, increase efficiency of clinical trials, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders. BACKGROUND: In Oct 2011, NINDS awarded the Clinical Coordinating Center (CCC) grant to MGH, the Data Coordinating Center (DCC) grant to the University of Iowa, and Clinical Study Sites (CSS) grants to 25 academic institutions. Three novel initiatives to increase the efficiency of conducting clinical trials in the Network were proposed: utilization of a Central IRB (CIRB) of record, establishment of Master Clinical Trial Agreements (MCTA) with all CSS, and availability of experienced trial design staff to assist principal investigators. DESIGN/METHODS: The CCC and DCC developed 50 Standard Operating Procedures for Network operations. The CIRB held teleconferences and one in person meeting with IRB leaders from the CSS. In Oct 2011, the NeuroNEXT Executive Committee (NEC) was established and began reviewing proposals. Those that met the goals and mission of NINDS, and were approved by the NEC, then proceeded to a Protocol Working Group (PWG) with the objective of designing the strongest protocol and grant application. RESULTS: All CSS executed Reliance Agreements with the CIRB (mean 25 days, range 1 to 43 days), and MCTA (mean 50 days, range 4 – 168 days). The first funded study was announced in April 2012. The study was submitted to the CIRB for full review on July 18 th , and received full CIRB approval on Aug 21 st , 2012. In year 1, 60 proposals were submitted to NINDS, 32 submitted to the NEC and 18 PWG were formed. Four grant applications were submitted to NINDS for review; with an additional 8 expected in Dec 2012. CONCLUSIONS: The NeuroNEXT Network has successfully established infrastructure that will greatly increase the efficiency and quality of clinical trials. Supported by: NINDS. Disclosure: Dr. Kearney has nothing to disclose. Dr. Ecklund has nothing to disclose. Dr. Simpson has nothing to disclose. Dr. Bosch has nothing to disclose. Dr. Sweet has nothing to disclose. Dr. Jackson has nothing to disclose. Dr. Mahoney has nothing to disclose. Dr. McCourt has nothing to disclose. Dr. Thornell has nothing to disclose. Dr. Titus has nothing to disclose. Dr. Soodoo has nothing to disclose. Dr. O9Brien has nothing to disclose. Dr. Gloer has nothing to disclose. Dr. Costigan has nothing to disclose. Dr. Logsden-Sackett has nothing to disclose. Dr. Huff has nothing to disclose. Dr. Shefner has received personal compensation for activities with Biogen-Idec and Glaxo SmithKline as a member of the advisory boards, and from Cytokinetics, Inc as a consultant. Dr. Shefner has received personal compensation in an editorial capacity for the Neuromuscular Section Editor of UpToDate. Dr. Shefner has received research funding from NIH, the ALS Association, the ALS Therapy Alliance, MDA, Glaxo Smith Kline, Isis Pharmaceuticals, Biogen-Idec, Cytokinetics, Inc., and Sanofi Pharmaceuticals. Dr. Gutmann has received research support from Allergan, Inc. and Cytokinetics. Dr. Clarke has nothing to disclose. Dr. Torner has received personal compensation for activities with BHR Pharmaceuticals and Actelion Pharmaceuticals as a consultant. Dr. Long has nothing to disclose. Dr. Chaloner has nothing to disclose. Dr. Bayman has received compensation for serving on the editorial board of Neurosurgery. Dr. McNeil has nothing to disclose. Dr. Koroshetz has nothing to disclose. Dr. Kaufmann has nothing to disclose. Dr. Cudkowicz has received personal compensation for activities with GlaxoSmithKline, Inc. and Teva Neuroscience. Dr. Cudkowicz has received research support from Biogen Idec and Neuraltis. Dr. Coffey has received personal compensation for activities with ZZ Biotech, LLC as a consultant.