NeuroNEXT is accelerating the implementation of clinical trials in neurological disease by centralizing data processing and institutional review board approval while also encouraging and developing a strong and stable multi-center infrastructure. Critical to the success of NeuroNEXT is the participation of institutions with dedicated clinician-researchers expert in a wide variety of neurological subspecialties serving a wealth of patients with a diverse array of conditions. In this competing continuation application, Boston Children's Hospital (BCH) joins forces with neighboring Beth Israel Deaconess Medical Center (BIDMC) to form a single clinical research site that can participate in clinical trials in adults and children across the disease spectrum, with conditions ranging from muscular dystrophy to multiple sclerosis to Huntington's disease. This new dual- institution clinical research site builds off an existing successful relationship in which both organizations have shared neurology residency and fellowship programs for the past 20 years as well as an R25 training grant program for the past seven years. Moreover, both institutions have had a close ongoing working relationship with a number researchers being credentialed at both hospitals.
Our specific aims of this proposal are: (1) to advance the BCH/BIDMC NeuroNEXT site as a shared infrastructure platform poised for the ready participation in a variety of neurology clinical trials; (2) to identify and recruit eligible patients for NeuroNEXT and other NINDS-funded trials; (3) to generate innovative trial applications for Network review, with the goal of being named lead CRS in a future NeuroNEXT study; (4) to collaborate effectively with the NeuroNEXT Data Coordinating Center, while demonstrating expertise in publication and dissemination of research results; (5) to abide by standardized Network policies, while also standardizing institutional, divisional, departmental, and individual collaborative agreements; and (6) to train new clinical investigators in skills required for an independent career in clinical research while maximizing site co-investigator use of local clinical research educational and support services. In summary, the BCH/BIDMC clinical research site will serve as an effective and enthusiastic participant in future studies generated by outside investigators while will also being a source for innovative ideas that will help propel clinical neuroscience forward and the identification of new, effective therapies for neurological disorders across the disease spectrum.
Building upon the success of our first NeuroNEXT funding period, in this application, Boston Children's Hospital joins forces with Boston's Beth Israel Deaconess Medical Center to form a new clinical research site that can participate fully in both adult and pediatric clinical trials. This site will offer an established infrastructure and a large group of physicians experienced in clinical trials who will be able to enroll patients with a wide variety of neurological disorders, helping to advance therapeutic testing broadly in the neurosciences.