In response to RFA-NS-11-008 we propose to establish a clinical trial site at Washington University in St. Louis (WUSTL) as a part of the Network of Excellence in Neuroscience Clinical Trials (NEXT) program proposed by the National Institute of Neurological Diseases and Stroke (NINDS). Under the leadership of David B Clifford, MD (PI/PD) for the WUSTL site, with the large clinical and research programs at WUSTL in neurological disorders led by experts in most disciplines of pediatric and adult neurology, and with well -developed research infrastructure including our Neurologic Clinical Research Unit (NCRU) and experience in clinical trials we will provide a highly productive and efficient contributor to the NEXT group.
Specific aims for this proposal are to: 1. Establish leadership for a Clinical Trials Site optimizing the ability of Washington University in St. Louis o be an effective contributing part of the Network for Excellence in Neuroscience Clinical Trials (NEXT) 2. Establish a plan for collaboration with the Clinical Coordinating Center (CCC), the Data Coordinating Center (DCC), and the potential co-investigators from Washington University in St. Louis to enhance productivity of the entire network, and specifically the WUSTL contributions to it 3. Establish a plan to facilitate recruitment and outreach supporting the conduct of NEXT trials that may include studies of uncommon neurological conditions 4. Establish a plan to leverage and support local clinical research resources particularly focusing on the NIH funded Institute of Clinical and Translational Sciences (ICTS) at Washington University and the Neuroclinical Research Unit (NCRU) 5. Establish means to optimize the efficiency of clinical research carried out at our site 6. Establish plan for performance monitorin to enhance the productivity of the WUSTL NEXT site 7. Establish plans to facilitate recruiting and training new professionals to contribute to the translational neuroscience programs at WUSTL and nationally
Emerging neuroscientific findings provide opportunities for new treatments for neurological disorders. Developing a highly efficient clinical trial network wil maximize the ability to study diverse neurological conditions. Effective sites will, like WUSTL, combine access to both children and adults, serve large clinical populations with diverse neurological disorders, include seasoned specialized investigators and establish efficient mechanisms to design and carry out high quality clinical trials.
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