This project will continue the Washington University NeuroNEXT site contributing to the Network of Excellence in Neuroscience Clinical Trials (NeuroNEXT sites) program. The overall goal of the program will contribute to the success in identifying and completing Phase 2 clinical trials that will speed translation of concepts to clinical practice for neurological conditions. The project will enhance the infrastructure for neuroscience related clinical trials at Washington University in St Louis (WUSTL) through supporting critical leadership personnel, support for the Neurological Clinical Research Unit (NCRU) and administrative infrastructure for multicenter clinical trials performance at WUSTL. The grant will provide key leadership assuring the efficient conduct of NeuroNEXT network clinical trials at WUSTL by funding a site PI and coordinator committed to assuring timely and accurate assessment of proposed concepts, organization and support of site protocol teams, and quality oversight for NeuroNEXT trials. The project also supports training for emerging investigators for participation in neurological clinical research through a program to support an outstanding younger investigator financially and through mentoring and formal training in theoretical and practical clinical trial practices, thus enriching the pool of investigators available for future investigations.
There are over 400 neurological disorders, many of which are hard to prevent, treat, or study due to low accrual numbers available in a single institution, but devastating to the lives of those affected. This clinical trial site is part of a network that supports an efficient multicenter group staffed and equipped to address such conditions by teams skilled in Phase 2 studies designed to gain critical data and biomarkers allowing definitive study of such conditions, ultimately resulting in more rapid application of theoretical hypotheses to improving the health and lives of those affected. In carrying out this mission, this group includes and mentors additional early phase investigators to enrich the pool of skilled clinical trialists so that future opportunities can be pursued with a better trained and larger group of qualified investigators.
