There is a current pressing need for a reliable and responsive neurologic clinical trial network that can conduct efficient and timely clinical trials f promising therapeutic agents. The goal of this proposal is to make Ohio State University (OSU) one of 25 Network of Excellence in Neuroscience Clinical Trials (NEXT) sites, and thereby participate in the development and execution of NEXT studies. OSU, as a comprehensive medical center that services a huge pediatric and adult referral population accounting for almost 2,000,000 outpatient and 75,000 inpatient visits) last year, is uniquely positioned to become a NEXT Center because of the extensive clinical trial experience of its neuroscience faculty in areas likely to be targeted by NEXT, its robust basic neuroscience research program, its comprehensive research infrastructure through the Center for Clinical and Translational Science (CCTS), and the major financial and programmatic commitment by OSU to basic and clinical neuroscience as one of six Signature Programs. Through this proposal, OSU can leverage these considerable resources to: 1) Develop a cost-effective infrastructure that can quickly and efficiently design and implement both pediatric and adult clinical trials encompassing the entire spectrum of neurologic diseases. 2) Recruit, enroll and retain subjects efficiently for each selected clinical study using a community outreach program to attract study participants and referrals from the entire region. This will entail implementing strategies to more effectively identify and recruit subjects for NEXT trials, and examine possible barriers to recruitment, participation, and retention. 3) Ensure the safety and rights of all participants in all trials thrugh informed consent procedures and confidentiality safeguards while minimize participant burden. 4) Use the NEXT initiatives and programs as a major component in training the next generation of neurologic clinician-scientists. At OSU, the significance and impact of NEXT funding will be immediate and profound, allowing us to consolidate clinical trial resources and integrate the efforts and components of the experienced neuroscience clinical trial groups more fully into the Neuroscience Signature Program and CCTS initiatives.
The NEXT program is a timely initiative that will develop an efficient and adaptive multicenter clinical trial network to foster the cooperation and coordinatio between sites needed to conduct efficient, timely trials of promising therapeutic agents in neurologic diseases. The program promises to fundamentally alter how neurologic trials are performed in this country by ensuring increased the efficiency and quality while reducing the costs of trials, and providing centers the opportunity to compare their performance to other centers studying the same disease to improve future trials.
| 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 |
| Kissel, John T; Elsheikh, Bakri; King, Wendy M et al. (2014) SMA valiant trial: a prospective, double-blind, placebo-controlled trial of valproic acid in ambulatory adults with spinal muscular atrophy. Muscle Nerve 49:187-92 |
| Collins, Michael P; Arnold, William David; Kissel, John T (2013) The neuropathies of vasculitis. Neurol Clin 31:557-95 |
